Clinical trial NCT02205151: To Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Fimasartan
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyunghee university hospital A Drug Analytical Laboratory
First posted: 2014-07-31
Enrollment: 86
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

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

Primary outcomes:
measure: (Cmax)
timeFrame: 0~144 hour after medication
measure: (AUClast)
timeFrame: 0~144 hour after medication
Secondary outcomes:
measure: (AUCinf)
timeFrame: 0~144 hour after medication
measure: (tmax)
timeFrame: 0~144 hour after medication
measure: (t1/2)
timeFrame: 0~144 hour after medication
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic university St. Mary hospital
Study officials:
affiliation: The Catholic university St. Mary hospital
name: seunghoon han, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: