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

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ClinicalTrials.gov Identifier: NCT02183571
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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)

Condition or disease Intervention/treatment Phase
Healthy Drug: Merck Glucophage® high dose Drug: BMS Glucophage® high dose Drug: Merck Glucophage® low dose Drug: BMS Glucophage® low dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalence of Two Strengths (1000 mg and 500 mg) of Two Different Metformin Tablets Administered to Healthy Male and Female Subjects in an Open, Randomised, Single-dose, Two-period Crossover, Phase I Trial
Study Start Date : February 2009
Actual Primary Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glucophage® high dose
Part I: Treatment A + B
Drug: Merck Glucophage® high dose
Part I: Treatment A

Drug: BMS Glucophage® high dose
Part I: Treatment B

Experimental: Glucophage® low dose
Part II: Treatment C+ D
Drug: Merck Glucophage® low dose
Part II: Treatment C

Drug: BMS Glucophage® low dose
Part II: Treatment D




Primary Outcome Measures :
  1. AUC0-infinity (area under the concentration-time curve of metformin in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 48 h after drug administration ]
  2. Cmax (maximum measured concentration of metformin in plasma) [ Time Frame: up to 48 hours after drug administration ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: up to 48 h after drug administration ]
  2. AUCt1-t2 (Area under the concentration time curve of metformin in plasma over the time interval t1 to t2) [ Time Frame: up to 48 h after drug administration ]
  3. tmax (time from dosing to the maximum concentration of metformin in plasma) [ Time Frame: up to 48 h after drug administration ]
  4. λz (terminal rate constant in plasma) [ Time Frame: up to 48 h after drug administration ]
  5. t1/2 (terminal half-life of metformin in plasma) [ Time Frame: up to 48 h after drug administration ]
  6. MRTpo (mean residence time of metformin in the body after po administration) [ Time Frame: up to 48 h after drug administration ]
  7. CL/F (apparent clearance of metformin in the plasma after extravascular administration) [ Time Frame: up to 48 h after drug administration ]
  8. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) [ Time Frame: up to 48 h after drug administration ]
  9. Number of patients with clinically relevant differences in physical examination [ Time Frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration ]
  10. Number of patients with clinically relevant differences in vital signs (BP (Blood pressure), PR (Pulse rate)) [ Time Frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration ]
  11. Number of patients with clinically relevant differences in 12-lead ECG (electrocardiogram) [ Time Frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration ]
  12. Number of patients with clinically relevant differences in clinical laboratory tests [ Time Frame: Baseline, day 1 prior, within 2-10 days following the last study drug administration ]
  13. Number of patients with adverse events [ Time Frame: within 2- 10 after last study drug administration ]
  14. Assessment of tolerability by investigator on a 4 point scale [ Time Frame: within 2- 10 after last study drug administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Any laboratory value outside the reference range that is of clinical relevance
  • Inability to comply with dietary regimen of trial site
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms)
  • A history of additional risk factors for Torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

For female subjects:

  • Positive pregnancy test, pregnancy or planning to become pregnant during the study or within 1 month after study completion
  • No adequate contraception during the study and until 1 month after study completion, i.e. not any of the following: implants, injectables, combined oral contraceptives, IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment, vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (including hysterectomy). Females, who do not have a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to use an additional barrier method (e.g. condom, diaphragm with spermicide)
  • Lactation

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183571    
Other Study ID Numbers: 1218.57
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs