Who is sponsoring NCT04186936?

NCT04186936 is sponsored by McNeil AB.

What drugs are being tested in NCT04186936?

Interventions: Combination Caplet with Loperamide HCl and Simethicone, Loperamide HCl, Simethicone.

What is the status of NCT04186936?

NCT04186936 is currently COMPLETED.

Last reviewed 2020-09-10 · How we verify

A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers

NCT04186936 PHASE1 COMPLETED

The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg (co-administered with Espumisan capsules with simethicone 40 mg), with respect to the single-dose pharmacokinetics of loperamide HCl. The maximum observed concentration (Cmax), and the area under the concentration-vs.-time curve until the last measurable concentration (AUC \[0-t\]) will be used to assess bioequivalence.

Details

Lead sponsor	McNeil AB
Phase	PHASE1
Status	COMPLETED
Enrolment	48
Start date	Thu Dec 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Dec 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Healthy

Interventions

Combination Caplet with Loperamide HCl and Simethicone
Loperamide HCl
Simethicone

Countries

Russia