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Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

Information source: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Glucophage SR tablet 750 mg, Crestor tablet 20 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hanmi Pharmaceutical Company Limited

Summary

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.

Clinical Details

Official title: Randomized, Open Label, Multiple-Dose, 6-sequence, 3-period, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium in Healthy Male Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Metformin, Rosuvastatin Cmaxss

metformin, rosuvastatin AUC

Secondary outcome:

Metformin, Rosuvastatin tmaxss

Metformin, Rosuvastatin t1/2

Metformin, Rosuvastatin C min,ss

Metformin, Rosuvastatin CL/Fss

Metformin, Rosuvastatin Vd/Fss

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Samgsung Seoul Hospital, Seoul, Korea, Republic of
Additional Information

Starting date: January 2013
Last updated: August 22, 2013

Page last updated: August 23, 2015

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