Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775579

HM-MERO-101

Details and patient eligibility

About

We investigate the potential pharmacokinetic drug-drug interaction between metformin extended release and rosuvastatin in healthy male volunteers who receive metformin extended release alone, rosuvastatin alone, and both together in a 3 period repeatedly.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteers, age 20 to 55 years.
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion criteria

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
3. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
4. Systolic blood pressure <90mmHg or Diastolic blood pressure < 60 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Crestor tablet 20 mg

Experimental group

Description:

Crestor tablet 20 mg single---\>wash out----\>Glucophage SR tablet 750 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Treatment:

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Glucophage SR tablet 750 mg and Crestor tablet 20 mg both

Experimental group

Description:

Glucophage SR tablet 750 mg, Crestor tablet 20 mg both---\>wash out----\>Glucophage SR tablet 750 mg single------\>washout---\>Crestor tablet 20 mg single

Treatment:

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

Glucophage SR tablet 750 mg

Experimental group

Description:

Glucophage SR tablet 750 mg single ---\>wash out----\>Crestor tablet 20 mg single----\>washout---\>Glucophage SR tablet 750 mg, Crestor tablet 20 mg both

Treatment:

Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg