anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Humulin N
Trial phase: Phase 4
ATC code: A10AE01
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: four-time daily in patients with T2DM admitted to general medicine and surgery wards.

sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards.
Eligibility criteria:
Inclusion Criteria:

Males or females between the ages of 18 and 75 years admitted to a general medicine or surgical services.
A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (sulfonylureas, meglitinides, metformin, thiazolidinediones, dipeptidyl peptidase (DPP) IV inhibitors).
Patients admitted for non-cardiac elective or emergency surgery or trauma.
Subjects must have an admission BG > 140 mg and < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalent /L, potential hydrogen (pH) < 7.30, or positive serum or urinary ketones).

Exclusion Criteria:

Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria [32].
Patients with acute critical or surgical illness admitted to the ICU or expected to require admission to the ICU.
Patients admitted for coronary artery bypass graft (CABG) or patients receiving continuous insulin infusion.
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.0 mg/dl).
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects are pregnant or breast feeding at time of enrollment into the study.
Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism.
Female subjects are pregnant or breast feeding at time of enrollment into the study.
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Atorvastatin 80mg po given prior to PCI in cath lab

Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab.
Eligibility criteria:
Inclusion Criteria:

patients undergoing revascularization for significant coronary artery disease
age range 21-85 years

Exclusion Criteria:

non-STEMI, STEMI
cancer
renal failure with creatinine>3.0mg/dl
liver cirrhosis
lymphoproliferative disorder
pregnancy
thrombocytopenia<150'000
coagulopathy (INR>1.5)
abnormal liver function tests
illicit drug use
history of statin intolerance
history of rhabdomyolysis
planned use of Glycoprotein IIb/IIIa inhibitors during PCI
current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin
Intervention: Ramipril
Trial phase: Phase 4
ATC code: C09AA05 | C09BA05 | C09BB05 | C09BB07 | C09BX03 | C09BX05 | C10BX04 | C10BX06 | C10BX17 | C10BX18
SMILES: [H][C@@]12CCC[C@]1([H])N(C(=O)[C@H](C)N[C@@H](CCc1ccccc1)C(=O)OCC)[C@H](C(=O)O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Ramipril 5mg/day

Ramipril: Ramipril 5 mg/day
Eligibility criteria:
Inclusion Criteria:

Between the ages of 40 and 65
Mean resting blood pressure between 130-160 systolic and 85-100 diastolic
Parent with Alzheimer's Disease

Exclusion Criteria:

Current involvement in another investigational drug trial.
Potassium > 5.0
Dementia based on DSMIV criteria
Mini-Mental State Exam (MMSE) score < 27
Current blood pressure medication (< 4 months from screening)
Weight loss medication
Contraindications for LP
Know diagnosis or history of hospitalization due to congestive heart failure
Elevated creatinine (females > 1.3 mg/dL or males > 1.4 mg/dL at baseline)
Diabetes Type I and II
Know adverse reaction to an ACE-I or an angiotensin receptor blocker
Pregnant of nursing women
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1276
Group description: Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Eligibility criteria:
Inclusion Criteria:

Male or female subjects > or = to 18 years of age.
Chronically impaired renal function.
Screening visit central laboratory hemoglobin < or = to 11.5 g/dL.
Screening ferritin < or = to 100 ng/mL or < or = to 300 when transferrin saturation (TSAT) is < or = to 30%.
If on an erythropoiesis stimulating agent(ESA) a stable dose (+/- 20%) for 4 weeks prior to randomization.

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose (FCM) or Venofer.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease OR is being considered for initiation of dialysis during the time period of this trial.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screening as determined by central labs greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active female subjects who are not willing to use an acceptable form of contraception.
Intervention: Duloxetine
Trial phase: Not Applicable
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Drug

duloxetine: Evaluate the analgesic effect of 30 mg duloxetine twice daily in comparison to matching placebo at baseline (BL) and follow up over a six week period
Eligibility criteria:
Inclusion Criteria:

Patients with chronic TMJD pain of two weeks duration
Age 18 and older
Confirmed craniofacial pain of nonodontogenic origin by the Research Diagnostic Criteria for temporomandibular disorders (TMD-RDC)
Concomitant medications are permitted, except those which may convey analgesia
Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding
Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using/willing to use a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility during the course of the study
Able to read and comprehend the rating scales, study instructions, and the consent form
Pain score of 4 or greater on the baseline VAS (0-10)

Exclusion Criteria:

Undergone any type of TMJ surgery or had TMJ growth disturbances, neoplasm, or injury to the TMJ area within the past six months
Taking analgesic or anti-inflammatory drugs, steroids, antidepressants, antiepileptics, or opioid medications that may confound the assessment of analgesia
Subjects with primary psychiatric diagnosis of major depression, suicidal ideation, or history of suicide attempt as assessed by medical history and the Mini International Neuropsychiatric Interview (MINI) are not eligible. Subjects with a score above average or higher in comparison with normative scores on the Beck Depression Inventory (BDI) will be allowed to participate

Exclusions based on the effects of duloxetine:

Known hypersensitivity to duloxetine or its inactive ingredients
Subjects with: renal impairment or end stage renal disease; urinary retention or hesitation, delayed gastric emptying; substantial alcohol use or evidence of chronic liver disease, hepatic insufficiency and hepatotoxicity; bleeding disorders, orthostatic hypotension, uncontrolled high blood pressure; recent history of myocardial infarction or unstable coronary artery disease; seizure disorder, history of bipolar disorder or mania, general anxiety disorder (GAD); hyponatremia; uncontrolled narrow-angle glaucoma.
Treatment with an monoamine oxidase inhibitor (MAOI) within 30 days of randomization, or potential need to use an MAOI during the study or within 5 days of discontinuation of the drug
Concomitant use of medications such as: NSAIDs, warfarin, aspirin or other drugs that affect coagulation; Thioridazine and inhibitors of CYP1A2 which affect metabolism of duloxetine; serotonergic drugs like triptans and MAOIs which increase the risk of Serotonin Syndrome; drugs that affect gastric acidity
Contraindications to acetaminophen use
Ever been treated with duloxetine
Intervention: Ketorolac
Trial phase: Phase 4
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
Eligibility criteria:
Inclusion Criteria:

clinical diagnosis of glaucoma
clinician has determined that SLT laser is indicated
IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

Exclusion Criteria:

prior history of uveitis
prior glaucoma surgery including glaucoma laser surgery
pregnant or 3 months post-partum
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 4
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
Eligibility criteria:
Inclusion Criteria:

clinical diagnosis of glaucoma
clinician has determined that SLT laser is indicated
IOP currently >18 and was ever >21 in the past (e.g. prior to treatment)

Exclusion Criteria:

prior history of uveitis
prior glaucoma surgery including glaucoma laser surgery
pregnant or 3 months post-partum
Intervention: Desmopressin
Trial phase: Phase 3
ATC code: H01BA02
SMILES: N=C(N)NCCC[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H]1CSSCCC(=O)N[C@@H](Cc2ccc(O)cc2)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 376
Group description: All participants received up to 750 mcg SER120 once daily
Eligibility criteria:
Inclusion Criteria:

Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
Willing to provide consent for the study

Exclusion Criteria:

Incontinence
Diabetes Insipidus, Diabetes Mellitus
CHF
Renal Insufficiency
Significant medical history which make participation unacceptable
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 246
Group description: Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥ to 18 years of age and able to give informed consent.
Diagnosis of Iron Deficiency Anemia (IDA).
Hemoglobin (Hgb) ≤ to 11 g/dL.
Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Intervention: Injectafer
Trial phase: Phase 3
SMILES: O.O=C([O-])C(O)C(O)C(OC1OC(CO)C(OC2OC(CO)C(OC3OC(CO)C(O)C(O)C3O)C(O)C2O)C(O)C1O)C(O)CO.[Fe+3].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 253
Group description: Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥ to 18 years of age and able to give informed consent.
Diagnosis of Iron Deficiency Anemia (IDA).
Hemoglobin (Hgb) ≤ to 11 g/dL.
Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.

aliskiren: aliskiren 300mg qd for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female ≥ 55 years of age
Symptomatic HFNEF of at least 1 month duration.
Reduced early diastolic mitral annular velocity by tissue Doppler
Left ventricular ejection fraction (LVEF ≥ 0.50)
Baseline exercise intolerance
Patients who are able to provide written informed consent
Stable medical therapy for 30 days prior to screening

Exclusion Criteria:

Seated blood pressure ≥ 160/90 mmHg at Visit 1 (screening)
Clinically significant pulmonary disease
Known history of documented EF < 0.45 at any time
Clinically unstable heart failure, medication changes for worsening heart failure symptoms within the past 4 weeks
Severe anemia (Hgb <10 mg/dL)
Clinical evidence of uncontrolled hypo or hyperthyroidism
Clinically significant valvular heart disease
Surgical correction of valvular heart disease within the last year
Known familial hypertrophic cardiomyopathy or hypertrophic obstructive cardiomyopathy
Known restrictive cardiomyopathy or systemic illness known to be associated with infiltrative myocardial disease (e.g. amyloidosis, sarcoidosis, hemachromatosis)
Pericardial restriction or hemodynamically significant pericardial effusion
Cor pulmonal or other causes of right heart failure not related to LV dysfunction
Extreme obesity (weight > 325 pounds)
Acute coronary syndrome within past 3 months
Coronary artery revascularization within past 3 months
Peripheral artery revascularization within past 3 months
Acute cerebrovascular syndrome (stroke or TIA) within the past 3 months
Uncontrolled symptomatic brady- or tachyarrhythmia
Creatinine > 2.5 mg/dl at screening
Potassium > 5.2 meq/l at screening
Prior treatment with, hypersensitivity to, intolerance of or contra-indication to aliskiren
Current treatment with antidepressant medication in the MAO(Monoamine Oxidase) inhibitor or SSRI(Selective serotonin reuptake inhibitors) class
Current participation in another clinical trial
Current treatment with both an ACE(Angiotensin-converting enzyme) inhibitor and an angiotensin receptor antagonist.
Known significant bilateral renal artery stenosis
Serious non-cardiovascular disease severely limiting life expectancy
Previous major organ (e.g., lung, liver, heart, kidney) transplantation or on a transplant waiting list
Any condition that is likely to prevent the patient from complying with the requirements of the study or completing the study (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no permanent home)
Pregnant women, nursing women, and women of childbearing potential.
Intervention: Maraviroc
Trial phase: Phase 1
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Maraviroc: 150mg twice daily
Eligibility criteria:
Inclusion Criteria:

HIV-1 infected males or females
signed informed consent
plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months

currently receiving a stable antiretroviral regimen comprising of:

tenofovir 245 mg daily
emtricitabine 200 mg daily
a boosted protease inhibitor
no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
Between 18 to 65 years of age, inclusive
subjects in good health upon medical history, physical exam, and laboratory testing

Female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study including 30 days following last dose of study drug:

barrier contraceptives (condom, diaphragm with spermicide)
IUD PLUS a barrier contraceptive
Female subjects of childbearing potential must have a negative pregnancy test.
Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 30 days following last dose of study drug.
Have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection by a HCV antibody or HCV PCR.
Have screening laboratory results (haematology, chemistry, and urinalysis) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance

Exclusion Criteria:

current alcohol abuse or drug dependence
active opportunistic infection or significant co-morbidities including dementia
current prohibited concomitant medication (as listed in section 4.1.4)
Have a body mass index (BMI) > 32

Contraindication to lumbar puncture examination. Such as:

Existing neurological diseases
Bleeding disorders
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to colchicine or ketoconazole or any other anti-fungal agent
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to colchicine or verapamil