Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01775579
First received: January 23, 2013
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Metformin, Rosuvastatin Cmaxss [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • metformin, rosuvastatin AUC [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metformin, Rosuvastatin tmaxss [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Metformin, Rosuvastatin t1/2 [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Metformin, Rosuvastatin C min,ss [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Metformin, Rosuvastatin CL/Fss [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Metformin, Rosuvastatin Vd/Fss [ Time Frame: 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) ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg
Experimental: Glucophage SR tablet 750 mg and Crestor tablet 20 mg both
Glucophage SR tablet 750 mg, Crestor tablet 20 mg both--->wash out---->Glucophage SR tablet 750 mg single------>washout--->Crestor tablet 20 mg single
Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg
Experimental: Glucophage SR tablet 750 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
Drug: Glucophage SR tablet 750 mg, Crestor tablet 20 mg

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775579

Locations
Korea, Republic of
Samgsung Seoul Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01775579     History of Changes
Other Study ID Numbers: HM-MERO-101
Study First Received: January 23, 2013
Last Updated: August 22, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypoglycemic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014