OBJECTIVE: To investigate the effects of multiple dosing with ranitidine (300 mg four times a day) on the absorption of a moderate dose of alcohol (0.5 gm.kg-1), consumed postprandially or on an empty stomach at different times of day, and to investigate if coadministration of ranitidine affects psychomotor function. METHODS: Two double-blind, randomized, two-way crossover, and placebo-controlled studies were performed in a university research establishment. Study subjects were 36 (18 in each study) normal, healthy, nonalcoholic men aged from 25 to 48 years. Subjects received either 300 mg ranitidine four times a day or placebo for 8 days with oral alcohol (0.5 gm.kg-1) in the morning on day 4, at midday on day 6, and in the evening on day 8. Alcohol was consumed 45 minutes after standard meals and 30 minutes after ranitidine in the first study; it was consumed on an empty stomach 30 minutes after ranitidine in the second study. RESULTS:Maximum blood alcohol concentrations, area under the blood alcohol concentration--time curve, and time to maximum concentration were not significantly different during ranitidine coadministration compared with coadministration of placebo. This result held true for each time of day and for fed and fasting states. Similarly, ranitidine had no detectable effect on any of the results from tests of psychomotor function. CONCLUSION: Irrespective of the time of day, ranitidine has no statistically or clinically significant effects on blood alcohol profiles.
RCT Entities:
OBJECTIVE: To investigate the effects of multiple dosing with ranitidine (300 mg four times a day) on the absorption of a moderate dose of alcohol (0.5 gm.kg-1), consumed postprandially or on an empty stomach at different times of day, and to investigate if coadministration of ranitidine affects psychomotor function. METHODS: Two double-blind, randomized, two-way crossover, and placebo-controlled studies were performed in a university research establishment. Study subjects were 36 (18 in each study) normal, healthy, nonalcoholic men aged from 25 to 48 years. Subjects received either 300 mg ranitidine four times a day or placebo for 8 days with oral alcohol (0.5 gm.kg-1) in the morning on day 4, at midday on day 6, and in the evening on day 8. Alcohol was consumed 45 minutes after standard meals and 30 minutes after ranitidine in the first study; it was consumed on an empty stomach 30 minutes after ranitidine in the second study. RESULTS: Maximum blood alcohol concentrations, area under the blood alcohol concentration--time curve, and time to maximum concentration were not significantly different during ranitidine coadministration compared with coadministration of placebo. This result held true for each time of day and for fed and fasting states. Similarly, ranitidine had no detectable effect on any of the results from tests of psychomotor function. CONCLUSION: Irrespective of the time of day, ranitidine has no statistically or clinically significant effects on blood alcohol profiles.