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

Yuhan

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteer

Treatments: Drug: Telmisartan; Drug: Rosuvastatin; Drug: Amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02233218

YH22189-101

Details and patient eligibility

About

To investigate the pharmacokinetic Drug-drug interaction

Full 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.

Enrollment: 60 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

telmisartan, Amlodipine, Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Amlodipine

Drug: Telmisartan

Telmisartan, Amlodipine, Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: Amlodipine

Drug: Telmisartan