Clinical trial NCT01068730: Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility 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

Primary outcomes:
measure: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
timeFrame: 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
measure: Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
timeFrame: 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
Secondary outcomes:
measure: Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
timeFrame: 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).
measure: Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE
timeFrame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
measure: Participants With Abnormal Physical Findings
timeFrame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
measure: Participants With Abnormal Vital Sign Findings Reported as an AE
timeFrame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
measure: Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology
timeFrame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
measure: Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry
timeFrame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
measure: Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis
timeFrame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Other outcomes:
measure: Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)
timeFrame: 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
measure: Metformin Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2)
timeFrame: 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
measure: Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])
timeFrame: 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
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: