A Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet

• Sponsor: Boryung Pharmaceutical Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02566187
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 49.4

Study Details

Study Description

Brief Summary

A phase I, Open-label, Randomized, Single-dose, 2 x 2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Atorvastatin Combination Tablet and Coadministration of Fimasartan and Atorvastatin as Individual Tablets in Healthy Male Volunteers.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Hyperlipidemia	Drug: Fimasartan/Atorvastatin Combination Tablet; Drug: Fimasartan; Drug: Atorvastatin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 Subjects of Group 1 take Fimasartan and Atorvastatin Individual Tablets at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 1 take a Fimasartan/Atorvastatin Combination Tablet at 8th day.	Drug: Fimasartan/Atorvastatin Combination Tablet; Drug: Fimasartan; Drug: Atorvastatin
Other: Group 2 Subjects of Group 2 take a Fimasartan/Atorvastatin Combination Tablet at 1st day as period I. And then, after wash out for 7 days, as period II, subjects of Group 2 take Fimasartan and Atorvastatin Individual Tablets at 8th day.	Drug: Fimasartan/Atorvastatin Combination Tablet; Drug: Fimasartan; Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

1. Maximum observed concentration(Cmax) of Fimasartan and Atorvastatin [0~48 hour after medication]

2. Area under the curve(AUCt) of Fimasartan and Atorvastatin [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:

• a Healthy male subject, aged 19- 50 years

Exclusion Criteria:

• History of clinically significant hypersensitivity to study drug, any other drug

• Hypotension or hypertension

• Active liver disease

• History of gastrointestinal disease

• History of excessive alcohol abuse

• Participation in any other study within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inje University Busan Paik Hospital	Busan		Korea, Republic of

Sponsors and Collaborators

• Boryung Pharmaceutical Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boryung Pharmaceutical Co., Ltd
• ClinicalTrials.gov Identifier: NCT02566187
• Other Study ID Numbers: BR-FAVC-CT-101
• First Posted: Oct 2, 2015
• Last Update Posted: Feb 25, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Hyperlipidemias; Atorvastatin

Study Results

No Results Posted as of Feb 25, 2016