Clinical trial NCT02397590: Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers
Official title: A Randomized, Open-label, Six-sequence, Three-period, Multiple Dosing Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin 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: Seoul National University Hospital
First posted: 2015-03-25
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A phase I clinical trial to compare the pharmacokinetics and safety of fimasartan/Atorvastatin combination tablet and coadministration of fimasartan and Atorvastatin in healthy male volunteers.

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

Group 1 period 2 period 3 period A F A F+A B F F+A A C A F+A F D A F F+A E F+A F A F F+A A F

At each period taking Fimasartan, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

At each period taking Atorvastatin, subjects of this Group have blood sampling 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48 hour after medication(12 times in each period).

At each period taking Fimasartan and Atorvastatin, subjects of this Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 and 48 hour after medication(15 times in each period).

Eligibility criteria: Inclusion Criteria:

1. Healthy male subject, aged 19- 50 years at screening.
2. Body weight between 19.0 and 28.0 of ideal body weight (IBW)(kg) = {height (cm) - 100} \* 0.9

Exclusion Criteria:

1. History of any illness that may affect the absorption, distribution, metabolism or excretion (hepatobiliary, renal, cardiovascular, endocrine (e.g., hypothyroidism), respiratory, gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system)
2. Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
3. Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
4. 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)\]
5. Participation in any other study within 2 months prior to the first administration of study drug (The finish time of previous study is the day of the last administration of study drug)

Primary outcomes:
measure: AUC tau,ss
timeFrame: Time Frame: 0~48 hour after medication
measure: Cmax,ss
timeFrame: Time Frame: 0~48 hour after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: