Type II Diabetes
Conditions
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
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Contacts
Primary ContactMin Soo Park, Ph.D.
Outcome results
None listed