Pharmacokinetics Evaluation of Acamprosate Tablets in Healthy Human Volunteers

Pharmacokinetic data of acamprosate tablets was not accessible on large number human. Rationale to examine the pharmacokinetic properties calcium in healthy male subject, single or multiple dosage administration, evaluate bioequivalence two formulations fast fed environment. This work engross study property Acamprosate dosing under fasting condition.
 Methods: Bioequivalence delayed release 333 mg for a randomized, dose, open label, treatment, periods, sequences and crossover design 12 healthy, adult human subjects condition conducted. The wash out period within each treatment stage 1 week. quantification done by LCMS/MS method. Accessibility evaluated monitoring adverse events, physical examinations ECG laboratory tests.
 Results: entire conducted using fulfill all stages study. calculations test reference are as follows: dosing, Tmax 8.54 ± 5.24 10.71 5.41 h, Cmax 146.06 99.73 115.01 ±86.26 ng · mL−1, AUC0-t 1391.95 731.24 1557.03 960.98 ng·mL−1·h, AUC0–∞ 1987.40 962.84 2720.21 1931.79 respectively. In three stages, 90% CIs test/reference ratio AUC0–t be found 80% –125% calcium.
 Conclusions: As per regulatory guidelines, pharmacokinetics parameters were acceptance criteria.