Bioequivalence Study of Two Strengths of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects

NCT02183571 | Completed Phase 1

• 1 other identifier: 1218.57
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Investigation of bioequivalence of BMS Glucophage® tablets and Merck Glucophage® tablets in the strengths of 1000 mg (part I) and 500 mg (part II)

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity)

  up to 48 h after drug administration

• Cmax (maximum measured concentration of metformin in plasma)

  up to 48 hours after drug administration

Secondary Outcomes (14)

• AUC0-tz (area under the concentration-time curve of metformin in plasma over the time interval from 0 to the time of the last quantifiable data point)

  up to 48 h after drug administration

• AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2)

  up to 48 h after drug administration

• tmax (time from dosing to the maximum concentration of metformin in plasma)

  up to 48 h after drug administration

• λz (terminal rate constant in plasma)

  up to 48 h after drug administration

• t1/2 (terminal half-life of metformin in plasma)

  up to 48 h after drug administration

Study Arms (2)

Glucophage® high dose

EXPERIMENTAL

Part I: Treatment A + B

Drug: Merck Glucophage® high dose; Drug: BMS Glucophage® high dose

Glucophage® low dose

EXPERIMENTAL

Part II: Treatment C+ D

Drug: Merck Glucophage® low dose; Drug: BMS Glucophage® low dose

Interventions

Merck Glucophage® high dose DRUG

Part I: Treatment A

Glucophage® high dose

BMS Glucophage® high dose DRUG

Part I: Treatment B

Glucophage® high dose

Merck Glucophage® low dose DRUG

Part II: Treatment C

Glucophage® low dose

BMS Glucophage® low dose DRUG

Part II: Treatment D

Glucophage® low dose

Eligibility Criteria

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

You may qualify if:

• Healthy males and females according to the following criteria: a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG) and clinical laboratory tests
• Age ≥ 18 and Age ≤ 55 years
• BMI ≥ 18.5 and ≤ 29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with Good clinical practice (GCP) and the local legislation

You may not qualify if:

• Any finding of the medical examination deviating from normal and of clinical relevance. Repeated measurement of a systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• Intake of drugs within one month or less than 10 half-lives of the respective drug prior to first study drug administration except if a relevant interaction can be ruled out
• Participation in another trial with an investigational drug within two months prior to first study drug administration
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in males)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to the start of study)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Design

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

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07