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Clinical Trial Details

Trial ID: L2360
Source ID: NCT01068730
Associated Drug: Metformin (Diabex)
Title: Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01068730/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: metformin (Diabex)|DRUG: metformin (Glucophageâ„¢)|DRUG: metformin (Glucophageâ„¢)|DRUG: metformin (Diabex)
Outcome Measures: Primary: 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., 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., 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: 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., 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., 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., 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, 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., 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., 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., From study drug administration Day 1/Period 1 till study discharge. Duration of the study was approximately 45 days (including screening). | Other: Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax), PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. Tmax is the time taken to reach the maximum observed plasma concentration., 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 Pharmacokinetic (PK) Parameter Terminal Half-life (T 1/2), PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. T 1/2 is the time required for the concentration of the drug to reach half of its original value in plasma, 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 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]), PK is the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body. AUC\[0-t\] is the area under the plasma concentration-time curve from time zero to time of last measurable concentration., 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
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2010-02
Completion Date: 2010-04
Results First Posted: 2012-03-29
Last Update Posted: 2015-05-08
Locations: PPD Development, LP, Austin, Texas, 78744, United States
URL: https://clinicaltrials.gov/show/NCT01068730