Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products

NCT01476683 | Completed Phase 1

• 1 other identifier: RACDIR1002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea

Keywords

Antidiarrheals

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• AUC(0-∞)

  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 Outcomes (4)

• Time of Maximum Concentration

  During 12 hours post-dose

• Terminal Elimination Rate Constant

  During 12 hours post-dose

• Terminal Phase Plasma Half-Life

  During 12 hours post-dose

• Lag Time

  During 12 hours post-dose

Study Arms (4)

FCT

EXPERIMENTAL

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

RPB

EXPERIMENTAL

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

TFT

ACTIVE COMPARATOR

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

TFR

ACTIVE COMPARATOR

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

Interventions

Racecadotril DRUG

Film-coated tablet

Also known as: Not yet marketed

FCT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

Algorithme Pharma Inc.

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Diarrhea

Interventions

racecadotril

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2011
• First Posted: November 22, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CA (1)