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

Information source: Yuhan Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Male Volunteer

Intervention: Telmisartan (Drug); Amlodipine (Drug); Rosuvastatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Yuhan Corporation

Official(s) and/or principal investigator(s):
Minkgyu Park, Ph.D, M.D., Principal Investigator, Affiliation: Dong-A university hospital of Korea

Summary

To investigate the pharmacokinetic Drug-drug interaction

Clinical Details

Official title: A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine

Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine

Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin

Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin

Secondary outcome:

Time of peak concentration in steady state of Telmisartan and Amlodipine

Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine

Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin

Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin

Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin

Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin

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.

Eligibility

Minimum age: 19 Years. Maximum age: 50 Years. Gender(s): Male.

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.

Locations and Contacts

Dong-A university hospital, Pusan, Korea, Republic of
Additional Information

Starting date: July 2014
Last updated: February 16, 2015

Page last updated: August 23, 2015

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