Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects

NCT01068730 | Completed Phase 1 Results

• 1 other identifier: CV181-120
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

Other Outcomes (3)

• Metformin Pharmacokinetic (PK) Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)

  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)

  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])

  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

Study Arms (4)

Treatment A

OTHER

500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition

Drug: metformin (Diabex)

Treatment B

OTHER

500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition

Drug: metformin (Glucophage™)

Treatment C

OTHER

1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition

Drug: metformin (Diabex)

Treatment D

OTHER

1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition

Drug: metformin (Glucophage™)

Interventions

metformin (Diabex) DRUG

Tablets, Oral, 500 mg, Once daily, single dose

Also known as: Diabex

Treatment A

metformin (Glucophage™) DRUG

Tablets, Oral, 500 mg, Once Daily, single dose

Also known as: Glucophage™

Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Boaz Hirschberg
• Organization: AstraZeneca Pharmaceuticals

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 8, 2015
• Results First Posted: March 29, 2012

Record last verified: 2015-03

Locations

US (1)