Skip to main content
OpenTrials
Completed

NCT Number: NCT02387619

The Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine

A randomized, open-label, multiple-dose, crossover study to investigate the pharmacokinetic drug interaction between rosuvastatin and telmisartan/amlodipine in healthy male volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yonsei University Health System

Seoul, Seodaemun-gu, 120-752, South Korea

About this study

A randomized, open-label, 2-treatment, 2-sequence, 2-period, multiple-dose, crossover design

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rosuvastatin

Drug

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days

Other names: Crestor

Telmisartan/Amlodipine

Drug

Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days

Other names: Twynsta

Rosuvastatin and Telmisartan/Amlodipine

Drug

Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days

Other names: Crestor and Twynsta

Primary outcomes

  1. AUCτ,ss , Cmax, ss of Rosuvastatin and Telmisartan, Amlodipine

    Time frame: 72hours, 144hours

Secondary outcomes

  1. AUClast,ss of Rosuvastatin

    Time frame: 72hours

  2. AUCinf,ss of Rosuvastatin

    Time frame: 72hours

  3. Tmax,ss of Rosuvastatin

    Time frame: 72hours

  4. t1/2 of Rosuvastatin

    Time frame: 72hours

  5. AUClast,ss of Telmisartan, Amlodipine

    Time frame: 144hours

  6. AUCinf,ss of Telmisartan, Amlodipine

    Time frame: 144hours

  7. Tmax,ss of Telmisartan, Amlodipine

    Time frame: 144hours

  8. t1/2 of Telmisartan, Amlodipine

    Time frame: 144hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan/Amlodipine in Healthy Male Volunteers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 13, 2015
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.