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

Launched by YUHAN CORPORATION · Sep 3, 2014

Keywords

ClinConnect Summary

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

Gender

MALE

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.