The objective of this study was to compare the single-dose oral bioavailability of metformin hydrochloride (HCI) liquid 500 mg/5 mL of Ranbaxy with GlucophageA® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female volunteers under fed conditions
This was an open-label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose crossover bioavailability study performed on 36 healthy adult male and female non-smoking or light smoking volunteers and 2 alternates. A total of 36 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 24-hour blood draw. Single oral 1000 mg doses were separated by a washout period of 7 days Of the 36 healthy adult non-smoking or light-smoking (10 cigarettes/day) volunteers and 2 alternates (19 males, 19 non-pregnant females) enrolled in the study, two did not complete the clinical phase of the study. Subject No. 11 was withdrawn from the study by the on-duty Physician after a positive pregnancy test prior to dosing in Period 2 and Subject No. 20 was withdrawn from the study by the Clinical Study Manager after she failed to complete her breakfast prior to dosing in Period 2. Thus a total of 36 subjects completed the clinical phase of the study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
36
MDS Pharma Services
Saint-Laurent, Quebec, Canada
Bioequivalence
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