Irritable bowel syndrome. Irritable bowel syndrome
Conditions
Interventions
Intervention 1: Intervention group: Mebeverin 135mg tablet, produced by Actover Co., (IRAN), single dose. Intervention 2: Control group: Duspatalin 135mg tablet, produced by Abbott Company, single dos
Sponsors
Actover Pharm. Co.
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Aged between 18 to 50 years Body weight between 50 to 100 kg Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent
Exclusion criteria
Exclusion criteria: Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of DMAC (demethylmebeverine acid) and Mebeverine acid. Timepoint: 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. Method of measurement: Using High Performance Liquid Chromatography wit Mass Spectrometer detector (HPLC/MS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLadan Tayebi
Pars Biopharmacy Research Co.
Outcome results
None listed