Clinical trial NCT03646799: Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Type II Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability after Oral Administration of CKD-387 10/1000 mg and D484 10/1000mg in Healthy Adults


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between the ages of 19 and 55
* Body weight ≥ 55kg for male, ≥ 50kg for female
* Body mass index ≥ 18.5 kg/m2 and \< 25.0 kg/m2
* Females who are post-menopausal or underwent sterilization
* Males who agreed to practice contraception until after 28 days of last intake Investigational product
* Ability to provide written informed consent

Exclusion Criteria:

* Subject with clinically significant hepatic, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular systemic disease and psychosis disorder
* Subject who are weak in dehydration or clinically significant dehydration
* IV injecting examination of radioactive-iodine substances within 48 hours prior to first IP administration
* Subjects who have Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subjects with history of gastrointestinal disease or surgery that may affect absorption of IP
* Hypersensitive to dapagliflozin/metformin
* At screening,

  * AST(Aspartate Transaminase), ALT(Alanine Transaminase) \> UNL(upper normal limit)\*1.25
  * Total Bilirubin \> UNL(upper normal limit)\*1.5, CPK \> UNL(upper normal limit)\*1.5
  * eGFR(estimated Glomerular Filtration Rate) \< 60 mL/min/1.73m2(Modification of diet in renal Disease calculated)
  * Positive reaction on following tests: Hepatitis B, Hepatitis C, HIV(Human Immunodeficiency Virus) and syphilis
  * SBP(Systolic blood pressure) ≥ 150 mmHg or \< 90 mmHg, DBP(Diastolic blood pressure) \> 100 mmHg or \< 50 mmHg
* History of drug abuse or positive urine drug screening results
* Women with pregnant, breast-feeding
* Caffeine \> 5 cups/day, Alcohol \> 210 g/week, Smoker \> 10 cigarettes /day or who are unable to stop caffeine intake, drinking alcohol and smoking until the last blood drawing for PK
* Subject who took ethical drug/herbal compound within 14 days, over-the-counter drug/vitamin supplements within 7 days and depot injection/implantation within 30 days prior to the first IP administration
* Subject who was enrolled in another clinical trial(including Bioequivalence study) and administered drugs within 90 days prior to the first IP administration
* Subject with whole blood donation within 60 days or component blood donation within 30 days
* Not eligible to participate for the study at the discretion of Investigator

Primary outcomes:
measure: Cmax of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: Cmax of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: AUClast of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: AUClast of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Secondary outcomes:
measure: AUCinf of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: AUCinf of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: Tmax of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: Tmax of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: T1/2 of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: T1/2 of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: Vd/F of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: Vd/F of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: CL/F of Dapagliflozin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
measure: CL/F of Metformin
timeFrame: Predose(0h), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24, 32, and 48 hour after drug administration
Other outcomes:
Locations:
city: Soeul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: