Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT03644095
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2018-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
Sponsor:
Reckitt Benckiser Inc.
Organization:
Study Overview
Official Title:
A Phase I, Open-label, Single-dose, Randomized, 2-way Crossover Bioequivalence Study Comparing Mucinex® SE Extended-Release 600 mg Bi-layer Tablet to a Reference Immediate-Release Guaifenesin 600 mg (Taken as 200 mg q4h) in Normal Healthy Subjects.
Status:
COMPLETED
Status Verified Date:
2019-06
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:
Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: