Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 Period 1: 1 tablet of reference drug(D484) Period 2: 1 tablet of test drug(CKD-387) |
Drug: CKD-387
test drug
Drug: D484
reference drug
|
| Experimental: Group 2 Period 1: 1 tablet of test drug(CKD-387) Period 2: 1 tablet of reference drug(D484) |
Drug: CKD-387
test drug
Drug: D484
reference drug
|
Outcome Measures
Primary Outcome Measures
- Cmax of Dapagliflozin [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]
Maximum plasma concentration of Dapagliflozin
- Cmax of Metformin [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]
Maximum plasma concentration of Metformin
- AUClast of Dapagliflozin [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]
Area under the plasma concentration-time curve to last concentration of Dapagliflozin
- AUClast of Metformin [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]
Area under the plasma concentration-time curve to last concentration of Metformin
Secondary Outcome Measures
- AUCinf of Dapagliflozin [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]
Area under the plasma concentration-time curve from zero to infinity concentration of Dapagliflozin
- AUCinf of Metformin [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]
Area under the plasma concentration-time curve from zero to infinity concentration of Metformin
- Tmax of Dapagliflozin [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]
Time to maximum plasma concentration of Dapagliflozin
- Tmax of Metformin [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]
Time to maximum plasma concentration of Metformin
- T1/2 of Dapagliflozin [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]
Half-life of Dapagliflozin
- T1/2 of Metformin [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]
Half-life of Metformin
- Vd/F of Dapagliflozin [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]
Apparent volume of distribution of Dapagliflozin
- Vd/F of Metformin [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]
Apparent volume of distribution of Metformin
- CL/F of Dapagliflozin [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]
Apparent clearance of Dapagliflozin
- CL/F of Metformin [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]
Apparent clearance of Metformin
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei University Severance Hospital | Soeul | Korea, Republic of |
Sponsors and Collaborators
- Chong Kun Dang Pharmaceutical
Investigators
- Principal Investigator: Min Soo Park, Ph.D., Severance Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 184BE18012