Clinical trial NCT04223895: A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
Official title: Phase I Clinical Trial to Compare the Pharmacokinetics and Tolerability of CKD-386 With Co-administration of D012, D326, and D337 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type2 Diabetes Mellitus
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and Safety/Tolerability of CKD-386

Detailed description: Phase I clinical trial to compare the pharmacokinetics and tolerability of CKD-386 with co-administration of D012, D326, and D337 in healthy adult volunteers

Eligibility criteria: Inclusion Criteria:

1. Those who are over 19 years old at the screening visit
2. Those who weigh more than 50kg (45kg or more for women) at the screening visit and have a body mass index (BMI) within the range of 18-30kg/m\^2
3. Those who meet the following conditions of blood pressure measured in a sitting position after sufficient rest at the screening visit

   * Systolic blood pressure: 90mmHg or more and 139mmHg or less
   * Diastolic blood pressure: 60mmHg or more and 89mmHg or less
4. Those who no congenital or chronic disease based on screening and no pathological symptoms or findings in medical examination results (e.g. EEG, ECG, chest and gastroscopy or gastrointestinal radiographs, if necessary)
5. The person in charge of the examination (or authorized test physician) who has determined that the test subject is suitable for the diagnostic test and electrocardiogram test such as hematology test, blood chemistry test, serology test and urine test performed according to the characteristics of the investigational drug product
6. Persons agreeing to exclude the possibility of pregnancy using appropriate contraceptive methods and not providing sperm or eggs from the date of first administration of the investigational drug to the 14th day after the last administration of the investigational drug

Exclusion Criteria:

1. Those who participated in other clinical trials (including bioequivalence studies) within 6 months before the first dose and received the investigational drug
2. Those who used drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within one month before the first dose, or who used drugs that may interfere with this test within 10 days before the first dose
3. Those who have donated whole blood within 2 months before the first dose or component donation within 1 month, or have transfused within 1 month
4. Those who have had a history of gastrointestinal resection that may affect the absorption of the investigational drug (except appendectomy and hernia surgery)
5. A person who meets the following conditions within one month before the first administration date

   * Excess alcohol: 21 cups / week for men and 14 cups / week for women.

     \[1 glass = 50 mL of shochu or 30 mL of liquor or 250 mL of beer\]
   * Smokers exceeding 20 cigarettes per day
6. Patients with the following diseases

   * Patients with hypersensitivity to the main constituents or components of the investigational drug
   * Severe hepatic impairment, biliary atresia or cholestasis
   * Patients with hereditary angioedema or with a history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor antagonists
   * Diabetes mellitus
   * Patients with moderate to severe renal impairment \[glomerular filtration rate (eGFR) \<60 mL / min / 1.73m\^2\]
   * Renal vascular hypertension patients
   * Patients with active liver disease, including unexplained persistent serum transaminase elevations or elevated serum transaminase elevations greater than three times the normal upper limit
   * Patients with myopathy or have a history of family or genetic history of myopathy
   * Hypothyroidism
   * If you have a history of muscle toxicity for other HMG-CoA converting enzymes or fibrate class drugs
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
8. person who is considered to be unsuitable for participation in this clinical trial for reasons other than the above selection / exclusion criteria.
9. In the case of female volunteers, the suspected or lactating woman

Primary outcomes:
measure: AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
measure: Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
Secondary outcomes:
measure: AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
measure: tmax each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
measure: AUCt/AUCinf each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
measure: t1/2 each main component or the metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D012, D326, D337
timeFrame: 0(predose)~72 hours
measure: AUCt of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
timeFrame: 0(predose)~72 hours
measure: Cmax of each main component or metabolite of the component after single dose of CKD-386 F1, CKD-386 F2 and D326, D337
timeFrame: 0(predose)~72 hours
Other outcomes:
Locations:
Study officials:
affiliation: H Plus Yangji Hospital
name: 70-4665-9174 70-4665-9174
role: PRINCIPAL_INVESTIGATOR
References: