NCT06297174

Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions

A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Racecadotril 100 mg Capsules and Reference Product (HIDRASEC®) in Healthy Thai Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Pharma Nueva · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Each subject will receive a single dose of racecadotril 100 mg capsules, as a test formulation (T) or a single dose of racecadotril 100 mg capsules, HIDRASEC, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water after an overnight fasting for at least 10 hours. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the capsule. This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing. The formulations will be given in a crossover fashion as per the randomization schedule. The dosing processes will be conducted under normal light condition. In each period, total of 23 blood samples will be collected from 23 sampling time points. Blood samples (3.5 mL each) will be collected at time 0.00 (pre-dose) and at 0.16, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 8.00, 12.00, 24.00 and 36.00 hours post-dose.

Conditions

• Healthy Vollunteer

Interventions

Type	Name	Description
DRUG	Racecadotril 100 mg Capsules	Racecadotril 100 mg Capsules (test drug)
DRUG	HIDRASEC®	HIDRASEC® (reference drug)

Timeline

• Start date: 2024-08-26
• Primary completion: 2024-09-17
• Completion: 2024-09-20
• First posted: 2024-03-07
• Last updated: 2024-03-07