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

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

Study Overview

• Status: Completed
• Conditions: Diabetes; Hyperlipidemia
• Intervention / Treatment: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-710
      • Samsung Medical Center(SMC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Metformin; Metformin and Rosuvastatin: Volunteers will be taken Metformin-Rosuvastatin-Co-administration	Drug: Metformin; Metformin,1000mg, once daily; Other Names: Glucodown OR SR tablet; Drug: Rosuvastatin; Rosuvastatin, 20 mg, once daily; Other Names: Crestor tablet; Drug: Metformin and Rosuvastatin; Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily; Other Names: Glucodown OR SR tablet and Crestor tablet
Experimental: Rosuvastatin; Metformin and Rosuvastatin: Volunteers will be taken Rosuvastatin-Co-administration-Metformin	Drug: Metformin; Metformin,1000mg, once daily; Other Names: Glucodown OR SR tablet; Drug: Rosuvastatin; Rosuvastatin, 20 mg, once daily; Other Names: Crestor tablet; Drug: Metformin and Rosuvastatin; Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily; Other Names: Glucodown OR SR tablet and Crestor tablet
Experimental: Co-administration; Metformin and Rosuvastatin: Volunteers will be taken Co-administration-Metformin-Rosuvastatin	Drug: Metformin; Metformin,1000mg, once daily; Other Names: Glucodown OR SR tablet; Drug: Rosuvastatin; Rosuvastatin, 20 mg, once daily; Other Names: Crestor tablet; Drug: Metformin and Rosuvastatin; Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily; Other Names: Glucodown OR SR tablet and Crestor tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax,ss, AUCτ	32h

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jeil Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jung-ryul Kim, MD, Ph.D, Samsung Medical Center(SMC)

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium; Metformin
• Other Study ID Numbers: JLP_1310-P1-DI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No