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
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)This study is designed to assess bioequivalence between two products used for treatment of acute diarrhea.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2011
Actual (reported)January 2011
Actual (reported)February 22, 2011
Actual (reported)February 23, 2011
Actual (reported)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
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
A single 100 mg dose of an experimental Racecadotril Film-Coated Tablet (FCT)
A single 100 mg dose of a marketed Racecadotril capsule
A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits
A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits
Algorithme Pharma Inc.
Mount Royal, Quebec, H3P 3P1, Canada
Elisabeth Kruse, PhD
McNeil AB
40 participants (actual enrollment reported by the registry).
First Submitted
February 22, 2011
First Posted
February 23, 2011
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of Racecadotril in Acute Watery Diarrhea in Children
Contact the study team to confirm eligibility.
Primary Completion
January 2011
Actual (reported)Study Completion
January 2011
Actual (reported)Last Updated
July 10, 2012
Record last verified: 2012-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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