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

Diabetes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186483
• Other study ID #: JLP_1310-P1-DI
• Status: Completed
• Phase: Phase 1
• First received: July 4, 2014
• Last updated: March 28, 2018
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2014
• Source: Jeil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Drug:
• Metformin
Metformin,1000mg, once daily
• Rosuvastatin
Rosuvastatin, 20 mg, once daily
• Metformin and Rosuvastatin
Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center(SMC)	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jeil Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax,ss, AUCt		32h
Secondary	Tmax,ss		32h
Secondary	t1/2		32h
Secondary	Cmin,ss		32h
Secondary	CL/Fss		32h
Secondary	Vd/Fss		32h