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Completed

NCT Number: NCT02089399

Pharmacokinetics and Drug Interaction Study Between Amlodipine,Olmesartan and Rosuvastatin in Healthy Adult Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between amlodipine, olmesartan and rosuvastatin in healthy adult volunteers.

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Key information

Conditions

Healthy

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

  • Healthy male subjects aged 19 - 55 years
  • A body mass index in the range 19 - 27 kg/m2
  • Willingness to participate during the entire study period
  • Written informed consent after being fully informed about the study procedures

Exclusion criteria

  • Any past medical history of hepatic, renal, gastrointestinal, respiratory, endocrine, psychiatric, neurologic, haemato-oncologic or cardiovascular disease
  • History of clinically significant drug hypersensitivity
  • Use of medication within 7 days before the first dose
  • Heavy drinker (>140 g/week)
  • Whole blood donation during 60 days before the study
  • Judged not eligible for study participation by investigator

Treatment and study plan

Sevikar(amlodipne/olmesartan)

Drug

Treatment AB

crestor(Rosuvastatin)

Drug

Treatment AB/Treatment C

Primary outcomes

  1. AUCtau

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

  2. Css,max

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Secondary outcomes

  1. Tss,max

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

  2. Css,min

    Time frame: Multiple blood sample will be collected for 24 hours after last dosing in each of the treatment

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

An Open Label, Randomized, 2-Sequence, Multiple-Dose, Cross-Over Study to Investigate the Drug-Drug Interaction of Sevikar and Crestor in Healthy Adult Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Apr 29, 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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