Clinical trial NCT04186936: A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2019-12-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Maximum Observed Concentration (Cmax)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Area Under the Plasma Concentration-tme Curve From Time Zero to Time 't' (AUC[0-t])
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Infinite Time (AUC[0-infinity])
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Area Under the Plasma Concentration-time Curve Extrapolated from Last Measurable Concentration to Infinite Time (AUCextrap)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Time to Reach Maximum Observed Concentration (Tmax)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Elimination Rate Constant (Lambda[z])
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Elimination Half-Life (t1/2)
timeFrame: Predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 10, 14, 24, 30, 36, 48, and 72 hours postdose
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 31 days
measure: Number of Participants with Adverse Events by Severity
timeFrame: Up to 31 days
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 17 days
measure: Number of Participants with Clinically Significant Change from Baseline in Vital Signs
timeFrame: Up to 31 days
measure: Number of Participants with Clinically Significant Change from Baseline in Laboratory Abnormalities
timeFrame: Up to 31 days
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: "Scientific and Research centre Eco-safety" Limited Liability Company
Study officials:
affiliation: McNeil AB
name: Konstantin Anatolyevich Zacharov
role: PRINCIPAL_INVESTIGATOR
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