To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

NCT ID: NCT02579356

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2014-08-31

Brief Summary

The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.

Conditions

Diseases of the Circulatory System; Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part1-A

The Part1-A of groups take Telmisartan once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Part1-B

The Part1-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan once a day for 6 days in period 2.

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Part2-A

The Part2-A of groups take Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Telmisartan and Atorvastatin once a day for 6 days in period 2.

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Part2-B

The Part2-B of groups take Telmisartan and Atorvastatin once a day for 6 days in period 1. After wash-out period, they take Atorvastatin once a day for 6 days in period 2.

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Atorvastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects between the ages of 19 and 55 years
• Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years
• Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
• Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
• Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)
• Twofold or more than upper limit of normal range in laboratory test for ALT or AST
• Participating in other clinical trial study within 2 month preceding the first dose of investigational product
• History of significant alcohol abuse or drug abuse within one year prior to the screening
• Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
• Unwilling or unable to comply with the lifestyle guidelines described in this protocol
• Subjects who are inadequate for this study to participate judged by investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chonbuk National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SI-1307

Identifier Type: -

Identifier Source: org_study_id