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Completed

NCT Number: NCT01831479

Investigation of Pharmacokinetic Interaction Between Rosuvastatin and Olmesartan in Healthy Male Volunteers

This study investigates pharmacokinetics and drug-drug interaction between Rosuvastatin and Olmesartan in healthy male volunteers

Completed

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Key information

Conditions

Healthy

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

Exclusion criteria

  • History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
  • Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
  • Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
  • Use of any substance that could induce or inhibit drug metabolism enzymes

Treatment and study plan

Rosuvastatin

Drug

Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days

Olmesartan

Drug

Single administration of olmesartan 40mg tablet QD for 7 consecutive days

Rosuvastatin and olmesartan

Drug

Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days

Primary outcomes

  1. Profile of Pharmacokinetics

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only

    Css,max, AUCtau

Secondary outcomes

  1. Profile of Pharmacokinetics

    Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose with a sample at 72 hr being taken for rosuvastatin only

    AUCss,last, AUCss,inf, Css,min, T_1/2

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2013
Registry last updated
Apr 15, 2013

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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