An Open Label Balance Randomized Two Treatment Two Secevence Two Period, Singledose Crose Over Oral Biogelivalence Study of Trimebutine 200mg and Digedrat In 48 Healthy Adult Human Subject Under Fasting Conditions.

The present study to investigate the bioequivalence of Trimebutine 200 mg capsules (Product Test).and Digedrat® (Product Reference) 200 mg capsules in 48 healthy, adult, human, male and non-pregnant female subjects under fasting conditions. To monitor adverse events and ensure safety of the subjects. The study, Trimebutine 200 mg (test) and Digedrat 200 mg (reference) capsules were evaluated for the safety upon single dose administration to normal healthy adult male and non pregnant females subjects under fasting conditions. There was a washout period of 5 days between the two periods. The overall duration of the study was 09 days including the wash out period. This study was conducted to establish the drugs concentration versus time profile and the results of the pharmacokinetic analysis of Trimebutine of the test(T) product were compared with the reference(R) product. The Means Plasma Concentration Vs various time points of both the Test and Reference products (Trimebutine), were similar,at all the scheduled time points. Analysis of variance for Ln-transformed pharmacokinetic parameters revealed that there was no significant variation between test and reference formulation for these three primary pharmacokinetic parameters Cmax and AUC0-t, & AUC0-�. The 90% confidence intervals of the T/R ratio of Ln- transformed Cmax, and AUC0-t , AUC0-� were within the bioequivalence range of 80%-125%. In conclusion, in the present study, Trimebutine 200 mg capsule is bioequivalent to Digedrat (Trimebutine) 200 mg tablet in 48 healthy subjects under fasting conditions. Trimebutine 200 mg capsule was well tolerated