A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Hypertension
- Interventions
- Registration Number
- NCT02704702
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects.
- Detailed Description
This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Caucasian male 19-55 years of age.
- Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history.
- Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
Exclusion Criteria
- History or presence of clinically significant medical or psychiatric condition or disease.
- Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
- Plasma donation within 7 days prior to the first dose of study drug.
- Participation in another clinical trial within 28 days prior to the first dose of study drug(s).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 (ABC) Fimasartan + Rosuvastatin Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period. Sequence 4 (BCA) Fimasartan + Rosuvastatin Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Sequence 3 (BAC) Fimasartan + Rosuvastatin Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period. Sequence 4 (BCA) Fimasartan Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Sequence 2 (ACB) Fimasartan + Rosuvastatin Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 2 (ACB) Rosuvastatin Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 6 (CBA) Fimasartan + Rosuvastatin Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Sequence 5 (CAB) Fimasartan + Rosuvastatin Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 1 (ABC) Fimasartan Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period. Sequence 1 (ABC) Rosuvastatin Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period. Sequence 2 (ACB) Fimasartan Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 3 (BAC) Fimasartan Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period. Sequence 3 (BAC) Rosuvastatin Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period. Sequence 4 (BCA) Rosuvastatin Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Sequence 5 (CAB) Fimasartan Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 5 (CAB) Rosuvastatin Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Sequence 6 (CBA) Fimasartan Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Sequence 6 (CBA) Rosuvastatin Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-time Curve For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Maximum Observed Concentration For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.
Time to Reach Maximum Observed Plasma Concentration For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period This Outcome is the time it takes a drug to reach Cmax
- Secondary Outcome Measures
Name Time Method