Skip to main content
OpenTrials
Completed

NCT Number: NCT02233218

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

To investigate the pharmacokinetic Drug-drug interaction

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Dong-A university hospital

Pusan, South Korea

About this study

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers aged 19 to 50
  • Participant who has a body weight that is >=55kg(male) and body mass index (BMI) level that is 18~30
  • Provision of signed written informed consent

Exclusion criteria

  • History of clinically significant disease
  • History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
  • A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
  • Administration of other investigational products within 2 months prior to the first dosing.
  • 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)
  • 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.

Treatment and study plan

Telmisartan

Drug

Amlodipine

Drug

Rosuvastatin

Drug

Primary outcomes

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

    Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Secondary outcomes

  1. Time of peak concentration in steady state of Telmisartan and Amlodipine

    Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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

    Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 8, 2014
Registry last updated
Feb 18, 2015

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.

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