MedTrace Logo

Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions

NCT06297174 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-03-07

No results posted yet for this study

Summary

Objectives:

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions

Study Design:

An open label, randomized, two-treatment, four-period, two-sequence, replicate crossover bioequivalence study in healthy Thai volunteers under fasting conditions with at least 7 days washout period between the administrations of investigational products of each period

Conditions

  • Healthy Vollunteer

Interventions

DRUG

Racecadotril 100 mg Capsules

Racecadotril 100 mg Capsules (test drug)

DRUG

HIDRASEC®

HIDRASEC® (reference drug)

Sponsors & Collaborators

  • Pharma Nueva

    lead INDUSTRY

Principal Investigators

  • Porranee Puranajoti · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2024-09-17
Completion
2024-09-20

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297174 on ClinicalTrials.gov