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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: McNeil AB
• Treatments: Racecadotril; Thiorphan

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.