Bioequivalence Study of Glimepiride 1mg Tablets Under Fed Conditions
Summary
The objective of this study is to compare the relative bioavailability of glimepiride 1 mg tablets (manufactured by Ranbaxy Laboratories Limited) with that of AMARYL® 1 mg tablets (following a single oral dose (1 x 1 mg tablet) in healthy, adult subjects under fed conditions.
Description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on glimepiride comparing glimepiride 1mg tablets of Ranbaxy laboratories limited with Amaryl 1mg tablets of in healthy, adult, human, subjects under fed conditions.
Thirty-two (32) subjects were recruited for this study and all subjects were healthy adults. Thirty-two (32) subjects began the study, and thirty-two (32) completed the clinical portion of the study.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Glimepiride 1mg Tablets
Location
Novum Pharmaceutical Research Services
Houston
Texas
United States
77042
Status
Completed
Source
Ranbaxy Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00776620
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
Tablets
Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed)
Excipients
Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc.
Talc
Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)
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