Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults

NCT01302093 | Completed Phase 1

• 1 other identifier: RACDIR1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.

Conditions

Antidiarrheals

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration

  Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)

  During 24 hours following drug administration

• Bioavailability [AUC(0-t)]

  Bioavailability \[AUC(0-t)\] is a measure of how much of the drug reaches the person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The Area Under the Curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour \* nanograms (ng) per milliliter (mL).

  During 24 hours post-dose

Secondary Outcomes (4)

• Bioavailability Extrapolated to Infinity [AUC (0-∞)]

  24 hours post-dose

• Time of Maximum Concentration

  During 24 hours post-dose

• Terminal Elimination Rate Constant

  During 24 hours post-dose

• Terminal Phase Plasma Half-Life

  During 24 hours post-dose

Study Arms (2)

Experimental Tablet

EXPERIMENTAL

A single 100 mg dose of an experimental Racecadotril Film-Coated Tablet (FCT)

Drug: Racecadotril Film-Coated Tablet (FCT)

Marketed Capsule

ACTIVE COMPARATOR

A single 100 mg dose of a marketed Racecadotril capsule

Drug: Racecadotril Capsule

Interventions

Racecadotril Film-Coated Tablet (FCT) DRUG

A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits

Also known as: Not yet marketed

Experimental Tablet

Racecadotril Capsule DRUG

A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits

Also known as: Tiorfast®

Marketed Capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects (equal numbers of males and females)
• \- Volunteers aged of at least 18 years but not older than 55 years
• \- Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight \>50 kg
• \- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
• \- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
• \- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
• \- Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
• \- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

You may not qualify if:

• Seated pulse rate below 45 bpm or higher than 90 bpm at screening
• Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
• Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
• Females who are pregnant or are lactating
• Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
• History of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Use of certain drugs/medications within protocol-specified timeframes
• Medical history or condition that may, per protocol or in the opinion of the investigator, adversely affect the safety of the study subject or compromise study results.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

racecadotril

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CA (1)