The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

NCT ID: NCT02233218

Last Updated: 2015-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-01-31

Brief Summary

To investigate the pharmacokinetic Drug-drug interaction

Detailed Description

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Conditions

Healthy Male Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

telmisartan, Amlodipine, Rosuvastatin

This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Telmisartan, Amlodipine, Rosuvastatin

This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers

Group Type: EXPERIMENTAL

Telmisartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Interventions

Telmisartan

Intervention Type: DRUG

Amlodipine

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male volunteers aged 19 to 50

2. Participant who has a body weight that is >=55kg(male) and body mass index (BMI) level that is 18~30

3. Provision of signed written informed consent

Exclusion Criteria

1. History of clinically significant disease

2. History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine

3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs

4. Administration of other investigational products within 2 months prior to the first dosing.

5. Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study)

6. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Minkgyu Park, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dong-A university hospital of Korea

Locations

Dong-A university hospital

Pusan, , South Korea

Countries

South Korea

Other Identifiers

YH22189-101

Identifier Type: -

Identifier Source: org_study_id