Article date: October 1993
By: H. G. DAMMANN, J. SIMON‐SCHULTZ, I. STEINHOFF, A. DAMASCHKE, A. SCHMOLDT, E. SALLOWSKY, in Volume 36, Issue 4, pages 345-349
The effects of oral misoprostol (800 μg day−1) and ranitidine (300 mg day−1) on the pharmacokinetics of diclofenac (100 mg) were assessed in a three‐way randomized crossover study in 18 healthy male subjects.
Subjects were studied over three 8 day periods, during which they received twice‐daily placebo, misoprostol, or ranitidine. A single dose of diclofenac was given orally on days 1 and 8, and plasma diclofenac concentrations were measured by h.p.l.c. over 24 h.
Misoprostol caused a non‐significant 19% increase in the mean Cmax value of diclofenac on both days 1 and 8. After 8 days of dosing with misoprostol there was a significant (P = 0.04) 20% decrease in the AUC of diclofenac.
Ranitidine had no statistically significant effects on the pharmacokinetics of diclofenac.
Co‐administration of misoprostol and diclofenac was associated with a higher frequency and severity of gastrointestinal symptoms and frequency of bowel opening, and a decrease in faecal consistency when compared with either placebo or ranitidine plus diclofenac (P < 0.01).
The effects of oral misoprostol (800 μg day−1) and ranitidine (300 mg day−1) on the pharmacokinetics of diclofenac (100 mg) were assessed in a three‐way randomized crossover study in 18 healthy male subjects.
Subjects were studied over three 8 day periods, during which they received twice‐daily placebo, misoprostol, or ranitidine. A single dose of diclofenac was given orally on days 1 and 8, and plasma diclofenac concentrations were measured by h.p.l.c. over 24 h.
Misoprostol caused a non‐significant 19% increase in the mean Cmax value of diclofenac on both days 1 and 8. After 8 days of dosing with misoprostol there was a significant (P = 0.04) 20% decrease in the AUC of diclofenac.
Ranitidine had no statistically significant effects on the pharmacokinetics of diclofenac.
Co‐administration of misoprostol and diclofenac was associated with a higher frequency and severity of gastrointestinal symptoms and frequency of bowel opening, and a decrease in faecal consistency when compared with either placebo or ranitidine plus diclofenac (P < 0.01).
DOI: 10.1111/j.1365-2125.1993.tb00374.x
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