Conditions: Hypertension
Keywords: Fimasartan
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 36
Healthy volunteers: yes

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.

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: 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.

Interventions: intervention 1: Fimasartan intervention 2: Rosuvastatin intervention 3: Fimasartan + Rosuvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: