A randomized, open label, single dose, crossover, bioequivalence study of Mebeverin 200mg capsule of Actover Co., IRAN and Clofac 200mg capsule of Solvey in 24 healthy adult subjects under fasting condition

A randomized, open label, single dose, crossover, bioequivalence study of Mebeverin 200mg capsule of Actover Co., IRAN and Clofac 200mg capsule of Solvey in 24 healthy adult subjects under fasting condition

A randomized, open label, single dose, crossover, bioequivalence study in 24 healthy subjects under fasting condition

This study is carried out in Core Research Center of Zahedan University of Medical Sciences located in Imam Ali Hospital in Zahedan. There is a separate space for sampling and forecasting emergency situations in order to accommodate and rest the volunteers. This crossover and open label study was performed on 24 healthy volunteers. The volunteers' health is verified by the project physician prior to entry into the study, and the volunteers' status is regularly monitored by the project physician on the day of drug administration. This study will be covered by insurance in order to compensate for any adverse effects.

Main Inclusion criteria: Healthy subjects aged between 18 -50 years old and weighted between 50 – 100 kg\\ Main exclusion criteria: Clinically relevant deviations from normal; Donation a unit of blood or participated in another clinical trial within the last three months; History of drug or alcohol abuse; Used any medication within 7- 14 days before the first treatment;

Intervention: Mebeverin 200mg capsule, produced by Actover Co., (IRAN), single dose. Control: Clofac 200mg capsule, produced by Solvey company, single dose.

Plasma concentration of DMAC (demethylmebeverine acid) and Mebeverine acid at 0 (before dosing), 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0 & 24.0 hr. after dosing

Names or codes assigned to volunteers are entered in a column of the Excel program. In the other column, using the rand command, a number between 0 and 1 is randomly assigned to each volunteer. Then, based on the order of the numbers (for example, from the smallest number to the largest), the first 12 people are placed in the AB sequence (test-reference) and the next 12 people are in the BA sequence (reference-test).