Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT01068730
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C metformin (Diabex) 1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition Treatment B metformin (Glucophage™) 500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition Treatment D metformin (Glucophage™) 1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition Treatment A metformin (Diabex) 500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition
- Primary Outcome Measures
Name Time Method Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf]) 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 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) 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 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
Name Time Method Participants With Abnormal Vital Sign Findings Reported as an AE From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening). per investigator
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs) 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). 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 From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). 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 From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening). Physical findings that were considered abnormal by the investigator.
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). Clinically significant was determined by the investigator.
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). Clinically significant was determined by the investigator.
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). Clinically significant was determined by the investigator.
Trial Locations
- Locations (1)
PPD Development, LP
🇺🇸Austin, Texas, United States