Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

• Registration Number: NCT01775579
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-25
• Primary Completion: 2013-03
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Metformin, Rosuvastatin Cmaxss	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
metformin, rosuvastatin AUC	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

Secondary Outcome Measures

Name	Time	Method
Metformin, Rosuvastatin t1/2	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
Metformin, Rosuvastatin C min,ss	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
Metformin, Rosuvastatin Vd/Fss	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
Metformin, Rosuvastatin tmaxss	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)
Metformin, Rosuvastatin CL/Fss	0h(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 9, 10, 12, 14, 24, 48 h of each period (total 16)

Trial Locations

Locations (1)

Samgsung Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of