Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

Diarrhea Clinical Trial

Official title:

An Open-Label, Fasting, Crossover, Single-Dose Pharmacokinetic Study of Four Formulations of Racecadotril

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476683
• Other study ID #: RACDIR1002
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2011
• Last updated: July 6, 2012
• Start date: December 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.

Description:

The study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). Subjects who drop out will not be replaced. The four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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) within protocol-specified parameters.

• 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 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 and blood pressure within protocol-specified parameters.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• Racecadotril
Film-coated tablet
• Racecadotril
Racecadotril Powder Blend
• Racecadotril
Marketed Capsule
• Racecadotril
Marketed Film-coated Tablet

Locations

Country	Name	City	State
Canada	Algorithme Pharma Inc.	Mount-Royal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McNeil AB

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration	No
Primary	AUC(0-t)	AUC(0-t) is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour*nanograms (ng) per milliliter (mL).	Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration	No
Primary	AUC(0-8)	AUC (0-8) is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.	Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration	No
Secondary	Time of Maximum Concentration	The time at which maximum concentration is reached (Tmax)	During 12 hours post-dose	No
Secondary	Terminal Elimination Rate Constant	The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose	During 12 hours post-dose	No
Secondary	Terminal Phase Plasma Half-Life	Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.	During 12 hours post-dose	No
Secondary	Lag Time	The time delay between drug administration and the quantification of absorption	During 12 hours post-dose	No