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

Phase 1

Completed

• Conditions: Hyperlipidemia; Diabetes
• Interventions: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin

• Registration Number: NCT02186483
• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-10
• Study Start: 2014-08
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Co-administration	Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
Metformin	Metformin	Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
Rosuvastatin	Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
Co-administration	Metformin and Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin
Rosuvastatin	Metformin and Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
Rosuvastatin	Metformin	Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin
Metformin	Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
Metformin	Metformin and Rosuvastatin	Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration
Co-administration	Metformin	Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin

Primary Outcome Measures

Name	Time	Method
Cmax,ss, AUCτ	32h

Secondary Outcome Measures

Name	Time	Method
Tmax,ss	32h
t1/2	32h
Cmin,ss	32h
CL/Fss	32h
Vd/Fss	32h

Trial Locations

Locations (1)

Samsung Medical Center(SMC); 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of