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Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01160068
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 13, 2010
Information provided by:
Dr. Reddy's Laboratories Limited

Brief Summary:

To compare the single dose bioavailability of Metformin Hydrochloride 1000 mg tablets (Dr. Reddy's Laboratories Ltd., Generics, India) with Glucophage (Metformin Hydrochloride) 1000 mg tablets (Bristol-Myers Squibb, USA) in 48 + (2 standby) healthy, adult, human subjects under fed conditions.

To monitor adverse events and to ensure the safety of subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Metformin Drug: Glucophage Phase 1

Detailed Description:
Open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,crossover bioequivalence study with at least 07 days of washout period between each drug administration under fed conditions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study of Metformin Hydrochloride 1000 mg Tablets (Dr. Reddy's Laboratories Ltd., Generics, India) to be Compared With Glucophage® (Metformin Hydrochloride) 1000 mg Tablets (Bristol-Myers Squibb, USA) in 48 + (2 Standby) Healthy, Adult, Human Subjects Under Fed Conditions
Study Start Date : February 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Metformin
Metformin Hydrochloride 1000 mg tablets of Dr. Reddy's Laboratories Limited
Drug: Metformin
Metformin Tablets 1000 mg
Other Name: Glucophage Tablets 1000 mg

Active Comparator: Glucophage
Glucophage 1000 mg tablets of Bristol-Myers Squibb
Drug: Glucophage
Glucophage 1000 mg tablets of Bristol-Myers Squibb

Primary Outcome Measures :
  1. Bioequivalence on Cmax, AUC, Tmax,t1/2 parameters [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who provided written informed consent.
  • Subjects who were healthy within 18-45 years of age (inclusive) weighing at least 50 kg.
  • Subjects who were within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
  • Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study.
  • Subjects with normal ECG, X-ray and vital signs.
  • Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent
  • If subject is a female volunteer and

    • is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device(IUD), or abstinence.
    • is postmenopausal for at least 1 year.
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

  • Subjects incapable of understanding the informed consent.
  • Subjects with BP:≤90/60 or BP≥140/90.
  • History of hypersensitivity or idiosyncratic reaction to Metformin or other Biguanides.
  • Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal, endocrine, immunologic, neurologic and haematologic function.
  • Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
  • Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical period.
  • History of any psychiatric illness, which may impair the ability to provide written, informed consent.
  • Subjects who have a history of alcohol or substance abuse within the last 5 years.
  • Subjects with clinically significant abnormal values of laboratory parameters.
  • Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
  • Subjects who tested positive at screening for HIV, HbsAg or HCV
  • Subjects with positive urine drug screen test for drugs of abuse.
  • Any subject in whom Metformin is contraindicated for medical reasons.
  • Subjects who have used any drugs or substances such as herbal preparations known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 14 days prior to the first dose.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01160068

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Vimta Labs Ltd.
Hyderabad, Andhra pradesh, India, 500051
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
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Principal Investigator: Mangesh Kulkarni, MD Vimta Labs Ltd.
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Responsible Party: Vice President-Generics, Dr. Reddy's Laboratories Limited Identifier: NCT01160068    
Other Study ID Numbers: 8322
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: July 13, 2010
Last Verified: January 2005
Additional relevant MeSH terms:
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Nutrition Disorders
Hypoglycemic Agents
Physiological Effects of Drugs