Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

July 6, 2012 updated by: McNeil AB

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Mount-Royal, Quebec, Canada, H3P 3P1
        • Algorithme Pharma Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FCT
A single 2 x100 mg dose of an experimental Racecadotril Film-coated tablet (FCT) administered orally with 240 ml of water, with a 7- day washout between visits.
Drug: Racecadotril
Film-coated tablet
Other Names:
  • Not yet marketed
Drug: Racecadotril
Racecadotril Powder Blend
Other Names:
  • Not yet marketed
Drug: Racecadotril
Marketed Capsule
Other Names:
  • Tiorfast®
Drug: Racecadotril
Marketed Film-coated Tablet
Other Names:
  • Tiorfanor®
Experimental: RPB
A single 2 x100 mg dose of an experimental Racecadotril Powder Blend administered orally with 240 ml of water, with a 7- day washout between visits.
Drug: Racecadotril
Film-coated tablet
Other Names:
  • Not yet marketed
Drug: Racecadotril
Racecadotril Powder Blend
Other Names:
  • Not yet marketed
Drug: Racecadotril
Marketed Capsule
Other Names:
  • Tiorfast®
Drug: Racecadotril
Marketed Film-coated Tablet
Other Names:
  • Tiorfanor®
Active Comparator: TFT
A single 2 x 100 mg dose of a marketed Tiorfast® capsule administered orally with 240 ml of water, with a 7-day washout between visits.
Drug: Racecadotril
Film-coated tablet
Other Names:
  • Not yet marketed
Drug: Racecadotril
Racecadotril Powder Blend
Other Names:
  • Not yet marketed
Drug: Racecadotril
Marketed Capsule
Other Names:
  • Tiorfast®
Drug: Racecadotril
Marketed Film-coated Tablet
Other Names:
  • Tiorfanor®
Active Comparator: TFR
A single 175 mg dose of a marketed Tiorfanor® 175 mg FCT administered orally with 240 ml of water, with a 7-day washout between visits.
Drug: Racecadotril
Film-coated tablet
Other Names:
  • Not yet marketed
Drug: Racecadotril
Racecadotril Powder Blend
Other Names:
  • Not yet marketed
Drug: Racecadotril
Marketed Capsule
Other Names:
  • Tiorfast®
Drug: Racecadotril
Marketed Film-coated Tablet
Other Names:
  • Tiorfanor®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration
Time Frame: 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
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
AUC(0-t)
Time Frame: 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
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
AUC(0-∞)
Time Frame: 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
AUC (0-∞) 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of Maximum Concentration
Time Frame: During 12 hours post-dose
The time at which maximum concentration is reached (Tmax)
During 12 hours post-dose
Terminal Elimination Rate Constant
Time Frame: During 12 hours post-dose
The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose
During 12 hours post-dose
Terminal Phase Plasma Half-Life
Time Frame: During 12 hours post-dose
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
Lag Time
Time Frame: During 12 hours post-dose
The time delay between drug administration and the quantification of absorption
During 12 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McNeil AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 17, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACDIR1002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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