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

This study is currently recruiting participants.
Verified February 2013 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01775579
First received: January 23, 2013
Last updated: February 8, 2013
Last verified: February 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

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 ]

Estimated Enrollment: 36
Study Start Date: January 2013
Estimated Study Completion Date: June 2013
Estimated 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.
  5. Hypersensitive reactions to metformin ingredient, rosuvastatin ingredient, or other drugs (aspirin, antibiotics ect.) or, history of clinically significant hypersensitive reactions
  6. History of drug, medication abuse or Positive urine screen
  7. Any systemic prescription drug or oriental medicine treatment within 14 days any systemic over-the-counter drug within 7 days before the first administration of study medication.
  8. Participation in another clinical trial within 60 days before the first administration of study medication.
  9. Component blood donation within 30 days or whole blood donation within 60 days or transfusions within 30days before the first administration of study medication.
  10. Administration of drugs which can inhibit or induce transporter proton pump inhibitor, rifampicin ect. within 30 days before the first administration of study medication.
  11. Consumption of more than 140g alcohol per week or impossible of stop drinking during period of subject confinement
  12. Smoking more than 10 cigarettes per one day or impossible of stop smoking during period of subject confinement.
  13. Positive serum test (HIV, Hepatitis B, Hepatitis C)
  14. Hereditary or family history of myopathy or, history of myopathy by drugs
  15. Inadequate for the clinical trial by the investigator's decision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775579

Contacts
Contact: jiyeon lee, bachelor 82-2-3410-6487 jy5802.lee@samsung.com

Locations
Korea, Republic of
Samgsung Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: jiyoen lee, bach·elor     82-2-3410-6487     jy5802.lee@samsung.com    
Sub-Investigator: tae-eun kim, MD, phD            
Samsung Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: jiyoen , bachler     82-2-3410-6487     jy5802.lee@samsung.com    
Sub-Investigator: tae-eun kim, MD,phD            
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: February 8, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013