Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP\_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP\_C003 after administration.
Detailed description
Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP\_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP\_C003 after Single Oral Administration to Healthy Male Subjects.
Interventions
DRUGRosuvastatin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
DRUGMetformin
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
DRUGBCWP_C003
Participant will be administered a single oral dose of BCWP\_C003 under Fasting condition or Fed condition according to sequence.
Sponsors
BC World Pharm Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
6 x 3
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Male Volunteer, age 19 to 45 years at the time of screening * Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0 * Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result * Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness
Exclusion criteria
* Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction * Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily * Subject who has family history of hereditary muscular disorder or muscular side effect * Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery) * Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration * Subject who has results of clinical laboratory test as follows : * AST, ALT level exceed the normal range more than 1.5 times * Total bilirubin level exceed the normal range more than 1.5 times * Creatinine clearance under 60mL/min calculated by MDRD * In the vital sign, systolic blood pressure is more than 150mmHg, less than 90mmHg or diastolic blood pressure is more than 95mmHg, less than 50mmHg * Subject who has presence or history of drug abuse, or positive screening for drug abuse → Alcohol abuse defines to drink over 21 unit/week(alcohol 1unit = 10g = 12.5 mL) persistingly * Subject who participated in another clinical trial within 3 month prior to the drug administration * Subject who had taken medicine(Barbital etc) related drug metabolizing enzyme induction or inhibition within 1 month prior to the drug administration * Subject who had taken prescription drug or oriental medicine within 2 weeks or OTC drug or vitamin formulation within a week prior to the drug administration * Subject who had a diet which can affect the absorption, distribution, metabolism or elimination of Rosuvastatin/Metformin (Particulary, Grapefruit - within 48h prior to the drug administration) * Subject who donated whole blood within 2 month or component blood within 1 month prior to the drug administration * Subject who smokes more than 10 cigarettes per day * Subject who has positive HBsAg, HCV Ab or HIV Ab * Subject who is judged to be ineligible by principal investigator or sub-investigator according to various test results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rosuvastatin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin Cmax |
| Metformin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Metformin AUClast |
| Rosuvastatin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin AUClast |
| Metformin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Metformin Cmax |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax |
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2 | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2 |
| N-desmethyl rosuvastatin Cmax | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | N-desmethyl rosuvastatin Cmax |
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F |
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F |
| N-desmethyl rosuvastatin AUClast | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | N-desmethyl rosuvastatin AUClast |
| N-desmethyl rosuvastatin AUCinf | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | N-desmethyl rosuvastatin AUCinf |
| Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf | pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h | Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf |
Countries
South Korea
Outcome results
None listed