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 Cmaxssmetformin, rosuvastatin AUC
Secondary outcome: Metformin, Rosuvastatin tmaxssMetformin, 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
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