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

NCT02205151 | Completed Phase 1 DMC

• 1 other identifier: BR-FAC-CT-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Keywords

Fimasartan

Outcome Measures

Primary Outcomes (2)

• (Cmax)

  0~144 hour after medication

• (AUClast)

  0~144 hour after medication

Secondary Outcomes (3)

• (AUCinf)

  0~144 hour after medication

• (tmax)

  0~144 hour after medication

• (t1/2)

  0~144 hour after medication

Study Arms (2)

Treatment AB

OTHER

Treatment A (1 day) → wash-out(14days) → Treatment B (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination

Drug: Fimasartan; Drug: Amlodipine; Drug: Fimasartan/Amlodipine combination

Treatment BA

OTHER

Treatment B (1 day) → wash-out(14days) → Treatment A (1 day) Treatment A : Fimasartanm and Amlodipine Treatment B : Fimasartan/Amlodipine combination

Drug: Fimasartan; Drug: Amlodipine; Drug: Fimasartan/Amlodipine combination

Interventions

Fimasartan DRUG

Treatment AB; Treatment BA

Amlodipine DRUG

Treatment AB; Treatment BA

Fimasartan/Amlodipine combination DRUG

Treatment AB; Treatment BA

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subject, aged 19- 50 years at screening.
• Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} \* 0.9
• 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

You may not qualify if:

• 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)
• History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).
• Subject that is judged inappropriate for participating in the study based on physical examination
• 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)
• Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
• systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes
• Take any other study's investigational products within 90 days prior to the first administration of study drug
• 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
• Intake food like Grapefruit juice (\*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug
• 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
• Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
• Subject that is judged inappropriate for participating in the study by an investigator, based any other reason

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead
• Kyunghee university hospital A Drug Analytical Laboratory: collaborator

Study Sites (1)

The Catholic university St. Mary hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Hypertension

Interventions

fimasartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• seunghoon han, M.D., Ph.D.

  The Catholic university St. Mary hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: July 31, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-07

Locations

KR (1)