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

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Amlodipine; Drug: Fimasartan; Drug: Fimasartan/Amlodipine combination

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).

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • The Catholic university St. Mary hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Treatment AB; Treatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination	Drug: Amlodipine; Drug: Fimasartan; Drug: Fimasartan/Amlodipine combination
OTHER: Treatment BA; Treatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination	Drug: Amlodipine; Drug: Fimasartan; Drug: Fimasartan/Amlodipine combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(Cmax)	0~144 hour after medication
(AUClast)	0~144 hour after medication

Secondary Outcome Measures

Outcome Measure	Time Frame
(AUCinf)	0~144 hour after medication
(tmax)	0~144 hour after medication
(t1/2)	0~144 hour after medication

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Collaborators: Kyunghee university hospital A Drug Analytical Laboratory
• Investigators: Principal Investigator: seunghoon han, M.D., Ph.D., The Catholic university St. Mary hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (ESTIMATE): July 31, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 13, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Fimasartan
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: BR-FAC-CT-101