The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine
Information source: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Hyperlipidemia
Intervention: Rosuvastatin (Drug); Telmisartan/Amlodipine (Drug); Rosuvastatin and Telmisartan/Amlodipine (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Jeil Pharmaceutical Co., Ltd. Official(s) and/or principal investigator(s):
Kyungsoo Park, MD, Ph.D., Principal Investigator, Affiliation: Yonsei University
Summary
A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic
drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers
Clinical Details
Official title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: AUCτ,ss of RosuvastatinCmax,ss of Rosuvastatin AUCτ,ss of Telmisartan, Amlodipine Cmax,ss of Telmisartan, Amlodipine
Secondary outcome: AUClast,ss of RosuvastatinAUCinf,ss of Rosuvastatin Tmax,ss of Rosuvastatin t1/2 of Rosuvastatin AUClast,ss of Telmisartan, Amlodipine AUCinf,ss of Telmisartan, Amlodipine Tmax,ss of Telmisartan, Amlodipine t1/2 of Telmisartan, Amlodipine
Detailed description:
A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design
Eligibility
Minimum age: 19 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 19~55 years healthy male
- Body weight is over 55kg, The result of Body Mass Index(BMI) is not less than 18
kg/m2 , no more than 27 kg/m2
- Subjects who agree to keep contraceptive methods during the clinical trial.
Exclusion Criteria:
- Subjects who are allergic to investigational drug.
- Subjects who have a medical history which can affect the clinical trial.
- Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic
BP ≤ 100mmHg or Diastolic BP ≤ 65mmHg)
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a
half times.
Locations and Contacts
Yonsei University Health System, Seoul, Seodaemun-gu 120-752, Korea, Republic of
Additional Information
Starting date: February 2015
Last updated: March 15, 2015
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