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Completed

NCT Number: NCT02579356

To Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

The study design was composed of 2 parts, 2-way crossover and multiple-dose. There are having 2 groups in each part that have divided period 1 and period 2, and wash-out period is 16 days between periods. Each group is taking Telmisartan (80mg) and/or Atorvastatin (80mg) once a day for 6 days.

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Key information

Conditions

Diseases of the Circulatory System Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chonbuk National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects between the ages of 19 and 55 years
  • Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years
  • Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
  • Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)
  • Twofold or more than upper limit of normal range in laboratory test for ALT or AST
  • Participating in other clinical trial study within 2 month preceding the first dose of investigational product
  • History of significant alcohol abuse or drug abuse within one year prior to the screening
  • Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
  • Unwilling or unable to comply with the lifestyle guidelines described in this protocol
  • Subjects who are inadequate for this study to participate judged by investigator

Treatment and study plan

Telmisartan

Drug

atorvastatin

Drug

Primary outcomes

  1. AUCt(0-24)

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  2. Css,max

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

Secondary outcomes

  1. Css,min

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  2. Css,av

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  3. Tss,max

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  4. t1/2

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  5. CL/F

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

  6. Vd/F

    Time frame: First, fourth, fifth, and sixth day. At 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post-dose in sixth day. (15 times)

Sponsors and collaborators

Lead sponsor

Samil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Between Telmisartan and Atorvastatin in Healthy Male Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2015
Registry last updated
Oct 19, 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.

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