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Completed

NCT Number: NCT02186483

Clinical Trial to Investigate the Pharmacokinetics Drug Interaction Between Metformin and Rosuvastatin

The purpose of this study is to investigate the pharmacokinetic drug interaction between Metformin and Rosuvastatin in healthy male volunteers.

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Key information

Conditions

Hyperlipidemia Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Samsung Medical Center(SMC)

Seoul, Gangnam-Gu, 135-710, South Korea

About this study

Drug-drug Interaction Following Co-administration of Metformin and Rosuvastatin in Healthy Male Volunteers

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
  • BMI measurement 19.0kg/m^2~ 28.0kg/m^2
  • Signed informed consent form from to participate voluntarily and to comply with the trial requirements.

Exclusion criteria

  • History of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
  • SBP>140mmHg or <90mmHg, DBP>90mmHg or <60mmHg.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • History of drug abuse
  • A alcohol consumer(alcohol>140g/week) or smoker(cigarette>10 cigarettes/day) Hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics)
  • Administrated investigational product in a previous clinical trial within 60 days of the screening day in this study.
  • Administrated drugs which can inhibit or induce OCT2, OATP1B1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin)
  • Glomerular filtration rate<60mL/min
  • Donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .

Treatment and study plan

metformin

Drug

Metformin,1000mg, once daily

Other names: Glucodown OR SR tablet

Rosuvastatin

Drug

Rosuvastatin, 20 mg, once daily

Other names: Crestor tablet

Metformin and Rosuvastatin

Drug

Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily

Other names: Glucodown OR SR tablet and Crestor tablet

Primary outcomes

  1. Cmax,ss, AUCτ

    Time frame: 32h

Secondary outcomes

  1. Tmax,ss

    Time frame: 32h

  2. t1/2

    Time frame: 32h

  3. Cmin,ss

    Time frame: 32h

  4. CL/Fss

    Time frame: 32h

  5. Vd/Fss

    Time frame: 32h

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate the Drug-drug Interaction Following Coadministration of Metformin and Rosuvastatin in Healthy Male Volunteers

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 10, 2014
Registry last updated
Mar 29, 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.

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