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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Hyperlipidemia Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin,1000mg, once daily

Rosuvastatin

Intervention Type DRUG

Rosuvastatin, 20 mg, once daily

Metformin and Rosuvastatin

Intervention Type DRUG

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

Rosuvastatin

Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin,1000mg, once daily

Rosuvastatin

Intervention Type DRUG

Rosuvastatin, 20 mg, once daily

Metformin and Rosuvastatin

Intervention Type DRUG

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

Co-administration

Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin,1000mg, once daily

Rosuvastatin

Intervention Type DRUG

Rosuvastatin, 20 mg, once daily

Metformin and Rosuvastatin

Intervention Type DRUG

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

Interventions

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Metformin

Metformin,1000mg, once daily

Intervention Type DRUG

Rosuvastatin

Rosuvastatin, 20 mg, once daily

Intervention Type DRUG

Metformin and Rosuvastatin

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

Intervention Type DRUG

Other Intervention Names

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Glucodown OR SR tablet Crestor tablet Glucodown OR SR tablet and Crestor tablet

Eligibility Criteria

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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 .

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes