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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02186483

Enrollment

Registered

2014-07-10

Start date

2014-08-31

Completion date

2015-02-28

Last updated

2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperlipidemia

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

Interventions

DRUGMetformin

Metformin,1000mg, once daily

DRUGRosuvastatin

Rosuvastatin, 20 mg, once daily

DRUGMetformin and Rosuvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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 .

Design outcomes

Primary

Measure	Time frame
Cmax,ss, AUCτ	32h

Secondary

Measure	Time frame
Tmax,ss	32h
t1/2	32h
Cmin,ss	32h
CL/Fss	32h
Vd/Fss	32h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026