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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
28
Tablets, Oral, 500 mg, Once daily, single dose
Tablets, Oral, 500 mg, Once Daily, single dose
Tablets, Oral, 1000 mg, Once daily, single dose
PPD Development, LP
Austin, Texas, United States
Metformin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])
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.
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
Metformin PK Parameter Observed Maximum Plasma Concentration (Cmax)
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.
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
Participants With Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs)
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.
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).
Participants With Electrocardiogram Abnormalities Considered Clinically Significant or Reported as an AE
Clinically significant was determined by the investigator. ECGs were recorded after participants had been supine for at least 5 minutes.
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Tablets, Oral, 1000 mg, Once daily, single dose
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Abnormal Physical Findings
Physical findings that were considered abnormal by the investigator.
Time frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Abnormal Vital Sign Findings Reported as an AE
per investigator
Time frame: From Day 1/Period 1 to study discharge or premature discontinuation. Duration of study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Hematology
Clinically significant was determined by the investigator.
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Serum Chemistry
Clinically significant was determined by the investigator.
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).
Participants With Clinical Laboratory Findings Considered Clinically Significant or Reported as an AE: Urinalysis
Clinically significant was determined by the investigator.
Time frame: From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening).