Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
- Registration Number
- NCT02397590
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.
- Detailed Description
After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.
Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F
At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).
At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- Healthy male subject, aged 19- 50 years at screening.
- Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
- History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
- Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
- Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)]
- Participation in any other study within 2 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B Group Atorvastatin Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) C Group Fimasartan Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) A Group Atorvastatin Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) A Group Fimasartan Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) E Group Atorvastatin Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) B Group Fimasartan Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) C Group Atorvastatin Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) D Group Atorvastatin Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) D Group Fimasartan Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) E Group Fimasartan Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) F Group Fimasartan Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) F Group Atorvastatin Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days)
- Primary Outcome Measures
Name Time Method AUC tau,ss Time Frame: 0~48 hour after medication Cmax,ss Time Frame: 0~48 hour after medication
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of