A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

Boryung

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Rosuvastatin; Drug: Fimasartan; Drug: Fimasartan + Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02704702

BR-FRC-CT-102

CA16652 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Caucasian male 19-55 years of age.
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion criteria

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within 7 days prior to the first dose of study drug.
5. Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Sequence 1 (ABC)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan

Sequence 2 (ACB)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan

Sequence 3 (BAC)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan

Sequence 4 (BCA)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan

Sequence 5 (CAB)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan

Sequence 6 (CBA)

Other group

Description:

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.

Treatment:

Drug: Fimasartan + Rosuvastatin

Drug: Rosuvastatin

Drug: Fimasartan