Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT02723669
Status:
COMPLETED
Last Update Posted:
2016-03-30
First Post:
2016-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of AR10 Compared to Reference Product
Sponsor:
Arbor Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study to Determine the Relative Bioavailability of AR10 (Acetylcysteine Effervescent Tablets) Compared to Reference Product in Healthy, Adult Subjects, Fasting
Status:
COMPLETED
Status Verified Date:
2016-03
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:
This study evaluates the relative bioavailability of Acetylcysteine Effervescent Tablets (AR10) and Reference N-acetylcysteine. Patients will receive both products in an Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover design.
Detailed Description:
An Open Label, Randomized, Two-Arm, Single-Dose, Two-Period, Crossover Study Relative Bioavailability Study. The present study is intended to compare and evaluate the relative bioavailability of a single 11 gram dose of AR10 (acetylcysteine effervescent tablets for oral solution (two 0.5 g and four 2.5 g\]), and the reference Listed Drug (acetylcysteine solution; oral 20% \[200 mg/mL\] of American Pharmaceutical Partners) in healthy adult, human subjects under fasting conditions. A balanced block randomization schedule will be generated before the start of dosing.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: