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

Sponsor
McNeil AB (Industry)
Overall Status
Completed
CT.gov ID
NCT01302093
Collaborator
(none)
40
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Racecadotril Film-Coated Tablet (FCT)
  • Drug: Racecadotril Capsule
 Phase 1

Detailed Description

The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females (minimum of 18 of either gender). Drop-outs will not be replaced. The two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 calendar days. In each study period, twenty (20) blood samples for pharmacokinetic analysis and, for the first 8 male and 8 female subjects included in the study (total of 16 subjects), seven (7) blood samples for pharmacodynamic analysis will be taken over 24 hours. Blood samples will be centrifuged and concentrations of thiorphan in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data. The rate and extent of absorption of the formulations will be compared.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Racecadotril 100 mg FCT Versus Tiorfast® 100 mg Capsules, in Normal, Healthy, Non-Smoking Male and Female Subjects
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Tablet

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

Drug: Racecadotril Film-Coated Tablet (FCT)
A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits
Other Names:
  • Not yet marketed

    		•
    Active Comparator: Marketed Capsule

    A single 100 mg dose of a marketed Racecadotril capsule

    Drug: Racecadotril Capsule
    A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits
    Other Names:
  • Tiorfast®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration [During 24 hours following 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)

    2. Bioavailability [AUC(0-t)] [During 24 hours post-dose]

      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).

    Secondary Outcome Measures

    1. Bioavailability Extrapolated to Infinity [AUC (0-∞)] [24 hours post-dose]

      Bioavailability Extrapolated to Infinity [AUC (0-∞)] is a calculated measure of how much of the drug will ever reach the person's bloodstream for the body to use. AUC (0-∞) stands for the area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (forever). It is obtained from calculating AUC (0-t) plus AUC (t-∞).

    2. Time of Maximum Concentration [During 24 hours post-dose]

      The time at which maximum concentration is reached (Tmax)

    3. Terminal Elimination Rate Constant [During 24 hours post-dose]

      The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose

    4. Terminal Phase Plasma Half-Life [During 24 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Algorithme Pharma Inc. Mount-Royal Quebec Canada H3P 3P1

    Sponsors and Collaborators

    • McNeil AB

    Investigators

    • Study Director: Elisabeth Kruse, PhD, McNeil AB

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    McNeil AB
    ClinicalTrials.gov Identifier:
    NCT01302093
    Other Study ID Numbers:
    • RACDIR1001
    First Posted:
    Feb 23, 2011
    Last Update Posted:
    Jul 10, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Racecadotril
    Thiorphan

    Study Results

    No Results Posted as of Jul 10, 2012