To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets

NCT ID: NCT02205151

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-09-30

Brief Summary

An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers

Detailed Description

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.

As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.

And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.

At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment AB

Treatment A (1 day) → wash-out(14days) → Treatment B (1 day)

Treatment A : Fimasartanm and Amlodipine

Treatment B : Fimasartan/Amlodipine combination

Group Type: OTHER

Fimasartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Fimasartan/Amlodipine combination

Intervention Type: DRUG

Treatment BA

Treatment B (1 day) → wash-out(14days) → Treatment A (1 day)

Treatment A : Fimasartanm and Amlodipine

Treatment B : Fimasartan/Amlodipine combination

Group Type: OTHER

Fimasartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Fimasartan/Amlodipine combination

Intervention Type: DRUG

Interventions

Fimasartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Fimasartan/Amlodipine combination

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subject, aged 19- 50 years at screening.

2. Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9

3. Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent

Exclusion Criteria

1. 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)

2. History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).

3. Subject that is judged inappropriate for participating in the study based on physical examination

4. The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal or eGFR < 60 mL/min/1.73m (calculated by MDRD)

5. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

6. systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes

7. Take any other study's investigational products within 90 days prior to the first administration of study drug

8. Donation of whole blood within 60 days prior to the first administration of study drug, or donation of any blood products within 30 days prior to the first administration of study drug

9. Intake food like Grapefruit juice (*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug

10. Use of any prescribed drugs or herbal remedies within 14 days, or use of any over-the-counter medication or vitamins within 7 days prior to the first administration of study drug

11. Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)

12. Subject that is judged inappropriate for participating in the study by an investigator, based any other reason

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kyunghee university hospital A Drug Analytical Laboratory

UNKNOWN

Sponsor Role: collaborator

Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

seunghoon han, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic university St. Mary hospital

Locations

The Catholic university St. Mary hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

BR-FAC-CT-101

Identifier Type: -

Identifier Source: org_study_id