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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 Rosuvastatin

Cmax,ss of Rosuvastatin

AUCτ,ss of Telmisartan, Amlodipine

Cmax,ss of Telmisartan, Amlodipine

Secondary outcome:

AUClast,ss of Rosuvastatin

AUCinf,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

Page last updated: August 23, 2015

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