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

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ClinicalTrials.gov Identifier: NCT01160042
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : July 26, 2010
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited

July 9, 2010
July 12, 2010
July 26, 2010
January 2005
April 2005   (Final data collection date for primary outcome measure)
Bioequivalence on Cmax, AUC, Tmax,t1/2 parameters [ Time Frame: 4 months ]
Same as current
Complete list of historical versions of study NCT01160042 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition
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 52 + (2 Standby) Healthy, Adult, Human Subjects Under Fasting Conditions

The objectives of this study are:

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 52 + (2 standby) healthy, adult, human subjects under fasting conditions.

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

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 fasting conditions.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • Drug: Metformin
    Metformin Tablets 1000 mg
    Other Name: Glucophage Tablets 1000 mg
  • Drug: Glucophage
    Glucophage 1000 mg tablets of Bristol-Myers Squibb
  • Experimental: Metformin
    Metformin Hydrochloride 1000 mg tablets of Dr. Reddy's Laboratories Limited
    Intervention: Drug: Metformin
  • Active Comparator: Glucophage
    Glucophage 1000 mg tablets of Bristol-Myers Squibb
    Intervention: Drug: Glucophage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
Same as current
April 2005
April 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01160042
8313
No
Not Provided
Not Provided
Vice President-Generics, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Mangesh Kulkarni, MD Vimta Labs Ltd.
Dr. Reddy's Laboratories Limited
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP