Trials / Completed
CompletedNCT04186936
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
An Open-label, Randomized, Fasting, Two-period, Single-dose, Crossover Study to Assess Bioequivalence Between a Combination Caplet With Loperamide Hydrochloride and Simethicone (Janssen-Cilag, France), and Imodium® Express Tablets-lyophilizate (Janssen-Cilag, France) Coadministered With Espumisan® Capsule (Berlin-Chemie AG, Germany), in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- McNeil AB · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Combination Caplet with Loperamide HCl and Simethicone | Participants will receive combination caplet with loperamide HCl 2 mg and simethicone 125 mg as Test product A per assigned treatment sequence. |
| DRUG | Loperamide HCl | Participants will receive loperamide HCl 2 mg tablet-lyophilizate orally as part of Reference product B per assigned treatment sequence. |
| DRUG | Simethicone | Participants will receive Simethicone 40 mg capsule orally as part of Reference product B per assigned treatment sequence. |
Timeline
- Start date
- 2019-12-05
- Primary completion
- 2019-12-26
- Completion
- 2019-12-26
- First posted
- 2019-12-05
- Last updated
- 2020-09-10
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04186936. Inclusion in this directory is not an endorsement.