Metabolic dynamics of dicyclomine hydrochloride in man as influenced by various dose schedules and formulations

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Danhof I, Schreiber E, Wiggans D, Leyland H

Metabolic dynamics of dicyclomine hydrochloride in man as influenced by various dose schedules and formulations

Toxicology and Applied Pharmacology. 1967 Dec 18;13(1):16-23.

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Abstract

Metabolic studies were conducted on each of four normal human male subjects, 20-30 years of age, weighing within the range of 150-180 pounds, to compare the absorption, plasma levels, and excretory routes of i4C-labeled dicyclomine hydrochloride utilizing four regimens, differing in dosage and form. Control and experimental periods, each of 7 days duration, were undertaken using fractional collection of blood, urine, and stool specimens. The four regimen studied in each subject included:(1) 3 x 10mg(8@i/l0 mg) capsules po; (2) 1 x 10 mg (8 @i/l0 mg) capsule po at 0, 4, and 8 hours; (3) 1 x 30mg (24@/ 30mg) tablet in a continuous release form, po; (4) 10mg (8 @i/l0 mg) in 10ml total volume, iv. The data indicate dicyclomine hydrochloride to be rapidly absorbed following oral administration; the drug and/or its metabolites are detectable in the urine within 1 hour. The principal route of elimination is via the urine(79.5% of the dose). Excretion also occurs via the feces, but to a lesser extent (8.4%). The average combined excretory recovery of drug in 4 subjects and 4 drug regimens was 87.9% in the 7 days after drug administration. Little difference in the average urinary recovery (76.3-82.1%) following various modes of administration was noted, suggesting that absorption was essentially complete in all cases including the continuous-release matrix form. Fecal recovery was somewhat more variable (5.2-15.3%).

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