Skip to main content
OpenTrials
Completed

NCT Number: NCT03461081

Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension With Hyperlipidemia

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center

Seoul, South Korea

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
  • The result of Body Mass Index(BMI) is not less than 19 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 ≤ 70mmHg)
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Treatment and study plan

telmisartan/amlodipine and atorvastatin

Drug

Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days

Primary outcomes

  1. AUCτ of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin

    Time frame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours

  2. Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin

    Time frame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2018
Registry last updated
Mar 12, 2018

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.