Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01068730
First received: February 12, 2010
Last updated: February 29, 2012
Last verified: February 2012
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Purpose
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: metformin (Diabex) Drug: metformin (Glucophage™) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets Manufactured by Bristol-Myers Squibb Relative to 500 mg and 1000 mg Diabex (Metformin) Tablets Marketed in Australia by Alphapharm Administered to Healthy Subjects in the Fed State |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) [ Time Frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing ] [ Designated as safety issue: No ]PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC (0-inf) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time.
- Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax) [ Time Frame: Periods 1, 2, 3, & 4: pre-dosing, 15, 30, 45 mins & 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36 & 48 hrs post-dosing ] [ Designated as safety issue: No ]PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Cmax is the maximum observed concentration of drug substance in plasma.
Secondary Outcome Measures:
- Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs) [ Time Frame: AEs: from study drug administration Day 1/Period 1 till study discharge. SAEs: from date of written consent until 30 days after discontinuation of dosing or study participation. Duration of the study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]AE=any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject administered an investigational product and that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that results in death, is life-threatening, requires or prolongs inpatient hospitalization (including elective surgery), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
- Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE [ Time Frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
- Participants With Abnormal Physical Findings [ Time Frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]Physical findings that were considered abnormal by the investigator.
- Participants With Abnormal Vital Sign Findings Reported as an AE [ Time Frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]per investigator
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology [ Time Frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]Clinically significant was determined by the investigator.
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry [ Time Frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]Clinically significant was determined by the investigator.
- Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis [ Time Frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). ] [ Designated as safety issue: Yes ]Clinically significant was determined by the investigator.
| Enrollment: | 28 |
| Study Start Date: | February 2010 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Treatment A
500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition
|
Drug: metformin (Diabex)
Tablets, Oral, 500 mg, Once daily, single dose
Other Name: Diabex
|
|
Treatment B
500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition
|
Drug: metformin (Glucophage™)
Tablets, Oral, 500 mg, Once Daily, single dose
Other Name: Glucophage™
|
|
Treatment C
1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition
|
Drug: metformin (Diabex)
Tablets, Oral, 1000 mg, Once daily, single dose
Other Name: Diabex
|
|
Treatment D
1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition
|
Drug: metformin (Glucophage™)
Tablets, Oral, 1000 mg, Once daily, single dose
Other Name: Glucophage™
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Men and women ages 18 to 55 inclusive
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ [height (m)]²
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- History of allergy or intolerance to metformin or other similar acting agents
- Prior exposure to metformin within 3 months of study drug administration
- Estimated creatinine clearance (Clcr) of < 80ml/min using the Cockcroft Gault formula
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01068730 History of Changes |
| Other Study ID Numbers: | CV181-120 |
| Study First Received: | February 12, 2010 |
| Results First Received: | January 20, 2012 |
| Last Updated: | February 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013