Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297174
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-29
Brief Title:
Bioequivalence Study of Generic Racecadotril 100 mg Capsules Under Fasting Conditions
Sponsor:
Pharma Nueva
Organization:
Pharma Nueva
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 2402 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 35 mL each will be collected at time 000 pre-dose and at 016 033 050 067 083 100 125 150 175 200 233 267 300 350 400 450 500 600 800 1200 2400 and 3600 hours post-dose
In each period total of 23 blood samples will be collected from 23 sampling time points Blood samples 35 mL each will be collected at time 000 pre-dose and at 016 033 050 067 083 100 125 150 175 200 233 267 300 350 400 450 500 600 800 1200 2400 and 3600 hours post-dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None