Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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