Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05737069
Status:
COMPLETED
Last Update Posted:
2023-05-31
First Post:
2023-02-10
Brief Title:
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
Sponsor:
HALEON
Organization:
HALEON
Study Overview
Official Title:
A Randomized Open-label Single-center Single-dose Two Treatment Two-sequence Two-period Two-cohort Two-way Crossover Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-05
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:
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram mg formulations under fasting and fed conditions in Chinese healthy adult participants The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations
Detailed Description:
The bioequivalence study adopts a single-center randomized open-label single-dose two-treatment two-sequence two-period two-cohort two-way crossover design with at least 2-day washout period under both fasting and fed conditions in Chinese healthy adult participants It will be planned to enroll approximately 84 participants out of which the first 34 participants for the fasted cohort and the subsequent 50 participants for the fed cohort receiving ibuprofen arginine granules 400 mg Participants will be randomly assigned to either one of the 2 treatment Test or Reference product sequences in a 11 ratio within fasted cohort and fed cohort
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