Pharmacokinetics of naproxen after oral administration of two tablet formulations in healthy volunteers. 1983

J Aarbakke, and G Gadeholt, and A Høylandskjaer

The pharmacokinetics of two naproxen tablet formulations were compared after oral administration. The 250-mg naproxen tablets, tablet I from AFI, Oslo, Norway, and tablet II Naprosyn, Astra-Syntex, were taken by 12 healthy volunteers in a randomized two-period crossover study. Plasma levels of naproxen were measured by a sensitive and specific HPLC method. The data were analyzed by means of two-way analysis of variance to test for significant differences between tablet formulation and differences between the first and second trial periods. Rapid absorption, with most Cmax values from 50-60 micrograms/ml reached within 1.5-3 h, was found for both tablet formulations. No significant difference was found in the rate and extent of absorption between the two formulations: the relative bioavailability of tablet I compared to tablet II was 1.05 +/- 0.21 (mean +/- SD). The naproxen concentration 2 h after ingestion and the Cmax were higher on the second occasion, regardless of preparation, suggesting that the subjects were clinically different on the two occasions.

UI MeSH Term Description Entries
D007408 Intestinal Absorption Uptake of substances through the lining of the INTESTINES. Absorption, Intestinal
D007700 Kinetics The rate dynamics in chemical or physical systems.
D008297 Male Males
D009288 Naproxen An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout. Aleve,Anaprox,Methoxypropiocin,Naprosin,Naprosyn,Naproxen Sodium,Proxen,Sodium Naproxenate,Synflex,Naproxenate, Sodium,Sodium, Naproxen
D005260 Female Females
D005746 Gastric Emptying The evacuation of food from the stomach into the duodenum. Emptying, Gastric,Emptyings, Gastric,Gastric Emptyings
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
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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