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Comparative bioavailability study of two tablet formulations of cimetidine
Biopharmaceutics & Drug Disposition
|April 1, 1984
Summary
Two cimetidine formulations were found to be bioequivalent in healthy males, showing no significant differences in key pharmacokinetic parameters. However, considerable individual variation in drug blood levels was noted between participants.
Area of Science:
- Pharmacokinetics
- Drug bioavailability
- Clinical pharmacology
Background:
- Cimetidine is a widely used medication for treating conditions related to stomach acid.
- Assessing the bioequivalence of different drug formulations is crucial for ensuring therapeutic equivalence and patient safety.
Purpose of the Study:
- To compare the bioavailability of two commercial cimetidine formulations.
- To determine if the two cimetidine products are bioequivalent in healthy male volunteers.
Main Methods:
- A two-way crossover study design was employed.
- Twenty-four healthy male volunteers participated in the study.
- Plasma and urine samples were collected over 12 hours post-administration for pharmacokinetic analysis.
Main Results:
- No statistically significant differences were observed in the mean pharmacokinetic parameters between the two cimetidine formulations.
- The study concluded that the two formulations are bioequivalent.
- Significant interpatient variability in cimetidine plasma concentrations was observed.
Conclusions:
- The two commercial cimetidine formulations are bioequivalent.
- Healthcare providers can be confident in substituting between these formulations.
- Further investigation into the causes of interpatient variability in cimetidine pharmacokinetics may be warranted.