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The effects of cimetidine and antacid on the pharmacokinetic profile of sildenafil citrate in healthy male volunteers.

Plain-language guide to PMID 11879257 (2002): open-label randomized controlled trial of Cimetidine and Magnesium Hydroxide in 22 volunteers.

Key Facts

PMID
11879257
Journal
British journal of clinical pharmacology
Year
2002
Study type
Randomized Controlled Trial
Authors
Wilner K et al. (3 authors)
DOI
10.1046/j.0306-5251.2001.00030.x

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of Cimetidine and Magnesium Hydroxide, published as a randomized controlled trial.

Blood samples were collected predose and at specified times up to 48 h postdose on days 1 and 5 to determine plasma levels of sildenafil and its metabolite, UK-103,320.

Who Took Part

According to the abstract, 22 volunteers were involved.

By PubMed's age tags, the people studied were adults and middle-aged adults, men only.

How the Study Was Run

The researchers set it up as a randomized, open-label, placebo-controlled, crossover and parallel-group study.

The volunteers were allocated by chance, so the Cimetidine group and the comparison group should start out alike.

Being open-label, the Cimetidine study did not mask who received what.

Some volunteers received a placebo instead of Cimetidine, giving a reference point.

Each person switched between Cimetidine and the comparison at some point, usually with a gap in between.

Blood samples were collected and analysed as in the first study.

The two study periods were separated by at least 14 days.

What Was Measured

PubMed files the paper under topics including Aluminum Hydroxide, Antacids, Anti-Ulcer Agents, Area Under Curve, Cimetidine, Drug Combinations and Half-Life.

What This Means in Plain Language

The paper is a randomized, open-label and placebo-controlled study of Cimetidine and Magnesium Hydroxide in 22 volunteers.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2002 (British journal of clinical pharmacology), a journal based in England.

More context: all human trials.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.