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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01160042 |
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Date of registration:
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09/07/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01160042 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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India
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Contacts
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Name:
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Mangesh Kulkarni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vimta Labs Ltd. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: Metformin
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Drug: Glucophage
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Primary Outcome(s)
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Bioequivalence on Cmax, AUC, Tmax,t1/2 parameters
[Time Frame: 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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