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

McNeil-PPC

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Simethicone; Drug: Loperamide HCl; Drug: Combination Caplet with Loperamide HCl and Simethicone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04186936

CO-161213141338-DHCT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) between 18.5 and 30.0 kilogram per meter (kg/m^2), inclusive, and a total body weight greater than or equal to (>=) 50.0 kilogram (kg)
• Females of childbearing potential must have a negative urine pregnancy test at the baseline visit
• Male or non-pregnant, non-lactating female agree to the contraceptive requirements (including female partner's use of a highly effective method of birth control for at least 3 months before the study, during the study and for 30 days after the last dose of investigational product)
• A personally signed and dated informed consent document before participating in any study specific procedures, indicating that the participant has been informed of all pertinent aspects of the study
• Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures specified in the protocol example: swallowing of tablets

Exclusion criteria

• Use of medications, prescription medication and/or over-the-counter medication including vitamins, herbal supplements, medicinal plants (example supplements containing garlic extract), and topical preparations of drugs that are systemically absorbed (example steroids and non-steroid anti-inflammatory drugs) within two weeks prior to dosing
• Use of St. John's wort (Hypericum perforatum) within 30 days prior to the first dose of study medication
• Abnormal results of laboratory and instrumental methods of examinations, including electrocardiogram (ECG)
• Females with a positive pregnancy test and/or are breast-feeding
• Females, currently using hormonal contraceptives (including use less than 2 months prior to enrollment)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Treatment Sequence AB

Experimental group

Description:

Participants will receive Test Product A (single dose of 2 caplets \[Combination caplet with loperamide hydrocloride \[HCl\] 2 milligram \[mg\] + simethicone 125 mg\]) orally on Day 1 followed by Reference Product B (single dose of 2 Imodium Express tablets-lyophilizate \[2\*2 mg loperamide HCl\] + 6 Espumisan capsules \[6\*40 mg simethicone\]) orally on Day 13. A washout period of at least 7 days will be maintained between each treatment.

Treatment:

Drug: Combination Caplet with Loperamide HCl and Simethicone

Drug: Loperamide HCl

Drug: Simethicone

Treatment Sequence BA

Experimental group

Description:

Participants will receive Reference product B orally on Days 1 followed by Test product A orally on Day 13. A washout period of at least 7 days will be maintained between each treatment.

Treatment:

Drug: Combination Caplet with Loperamide HCl and Simethicone

Drug: Loperamide HCl

Drug: Simethicone