Study to Evaluate the Pharmacokinetic Interaction Between Fimasartan and Atorvastatin in Healthy Male Volunteers

Sponsor

Boryung Pharmaceutical Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT02397590

Collaborator

Seoul National University Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

11.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Fimasartan Drug: Atorvastatin	Phase 1

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

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 Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: A Group Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days)	Drug: Fimasartan Drug: Atorvastatin
Other: B Group Fimasartan (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days)	Drug: Fimasartan Drug: Atorvastatin
Other: C Group Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days)	Drug: Fimasartan Drug: Atorvastatin
Other: D Group Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan+Atorvastatin (7 days)	Drug: Fimasartan Drug: Atorvastatin
Other: E Group Fimasartan+Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days) → wash out (7days) → Atorvastatin (7 days)	Drug: Fimasartan Drug: Atorvastatin
Other: F Group Fimasartan+Atorvastatin (7 days) → wash out (7days) → Atorvastatin (7 days) → wash out (7days) → Fimasartan (7 days)	Drug: Fimasartan Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

AUC tau,ss [Time Frame: 0~48 hour after medication]
Cmax,ss [Time Frame: 0~48 hour after medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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)
Hypotension (systolic ≤ 100 mmHg or diastolic ≤ 65 mmHg) or hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg), measured at screening
Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
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)]
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Boryung Pharmaceutical Co., Ltd
Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boryung Pharmaceutical Co., Ltd

ClinicalTrials.gov Identifier:

NCT02397590

Other Study ID Numbers:

BR-FMS-CT-117

First Posted:

Mar 25, 2015

Last Update Posted:

Jul 23, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Boryung Pharmaceutical Co., Ltd

Fimasartan

Additional relevant MeSH terms:

Hypertension

Atorvastatin

Study Results

No Results Posted as of Jul 23, 2015