NCT00778115

Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions

A Relative Bioavailability Study of Loperamide HCl 2 mg and Simethicone 125 mg Tablets to Imodium® Advanced Caplets Under Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in healthy subjects under fasting condition

Detailed description

The study was conducted as a single-dose, randomized, 2-period sequence crossover study under fasting condition comparing equal dose of test and reference products with an interval period of at least 7 days. The period of confinement was at least 10 hours before dosing until after 24 hours blood collection in each period. Subjects were asked to return to the clinic for subsequent blood circulation Twenty-six subjects (26) were recruited for the study of which twenty-three (23) completed the clinical portion of the study. Subject #17 was withdrawn by sponsor's representative due to adverse event unrelated to the drug), subject #18 and subject #25 voluntarily withdrew due to adverse event

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Loperamide HCl 2 mg and simethicone 125 mg tablets

Timeline

• Start date: 2004-11-01
• Primary completion: 2004-11-01
• Completion: 2004-12-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States