A pharmacokinetic study on two sustained-release formulations of indomethacin in normal subjects following a single dose administration. 1994

M M Hasan, and N M Najib, and H Y Muti
Department of Pharmacology, Faculty of Medicine, Jordan University of Science and Technology, Irbid.

A single dose pharmacokinetic study was conducted on two sustained-release formulations (75 mg) of indomethacin (Indocid capsules 'A' and Indogesic tablets 'B'). The study was carried out on 22 healthy male volunteers, who received a single oral dose (75 mg) of each product according to a randomized crossover design. Blood samples were obtained over a 24 h period, and drug concentrations were determined by an HPLC assay. The two products were not found to be statistically different with respect to the lag time between dosing and first appearance of the drug in the serum (1.0 +/- 0.1 and 0.9 +/- 0.1 h for A and B, respectively), or in the time needed to attain the peak concentrations (3.3 +/- 0.3 and 3.3 +/- 0.5 h for A and B, respectively). The two products, however, varied significantly in the peak serum concentrations (2721 +/- 220 and 1797 +/- 129 ng/ml for A and B, respectively). In terms of the extent of absorption, assessed by estimating the area under the concentration-time curve over 24 h, the two products were not found to be significantly different (11,575 +/- 630 and 10,212 +/- 556 ng . h/ml for A and B, respectively). Based on these findings, the two formulations can be considered bioequivalent in the extent but not in the rate of drug absorption.

UI MeSH Term Description Entries
D007213 Indomethacin A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES. Amuno,Indocid,Indocin,Indomet 140,Indometacin,Indomethacin Hydrochloride,Metindol,Osmosin
D008297 Male Males
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D003692 Delayed-Action Preparations Dosage forms of a drug that act over a period of time by controlled-release processes or technology. Controlled Release Formulation,Controlled-Release Formulation,Controlled-Release Preparation,Delayed-Action Preparation,Depot Preparation,Depot Preparations,Extended Release Formulation,Extended Release Preparation,Prolonged-Action Preparation,Prolonged-Action Preparations,Sustained Release Formulation,Sustained-Release Preparation,Sustained-Release Preparations,Timed-Release Preparation,Timed-Release Preparations,Controlled-Release Formulations,Controlled-Release Preparations,Extended Release Formulations,Extended Release Preparations,Slow Release Formulation,Sustained Release Formulations,Controlled Release Formulations,Controlled Release Preparation,Controlled Release Preparations,Delayed Action Preparation,Delayed Action Preparations,Formulation, Controlled Release,Formulations, Controlled Release,Prolonged Action Preparation,Release Formulation, Controlled,Release Formulations, Controlled,Sustained Release Preparation,Timed Release Preparation,Timed Release Preparations
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D013607 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) Tablet

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