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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01160042
First received: July 9, 2010
Last updated: July 22, 2010
Last verified: January 2005
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Metformin
Drug: Glucophage
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 52 + (2 Standby) Healthy, Adult, Human Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax, AUC, Tmax,t1/2 parameters [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 54
Study Start Date: January 2005
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 fasting conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160042

Locations
India
Vimta Labs Ltd.
Hyderabad, Andhra pradesh, India, 500051
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Mangesh Kulkarni, MD Vimta Labs Ltd.
  More Information

No publications provided

Responsible Party: Vice President-Generics, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01160042     History of Changes
Other Study ID Numbers: 8313
Study First Received: July 9, 2010
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014