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

Jeil Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes; Hyperlipidemia

Treatments: Drug: Metformin; Drug: Rosuvastatin; Drug: Metformin and Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186483

JLP_1310-P1-DI

Details and patient eligibility

About

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

Full description

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

Enrollment: 24 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Metformin

Experimental group

Description:

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

Treatment:

Drug: Metformin and Rosuvastatin

Drug: Rosuvastatin

Drug: Metformin

Rosuvastatin

Experimental group

Description:

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

Treatment:

Drug: Metformin and Rosuvastatin

Drug: Rosuvastatin

Drug: Metformin

Co-administration

Experimental group

Description:

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

Treatment:

Drug: Metformin and Rosuvastatin

Drug: Rosuvastatin

Drug: Metformin