Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03381664
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2017-12-18
Brief Title:
Study to Assess the Bioavailability Pharmacokinetics Safety and Tolerability of AVP-923 in Healthy Adult Participants
Sponsor:
Avanir Pharmaceuticals
Organization:
Avanir Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Randomized Single-Dose 3-Way Crossover Study to Compare the Relative Bioavailability Pharmacokinetics Safety and Tolerability of AVP-923 Dextromethorphan Hydrobromide and Quinidine Sulfate Capsules Administered in Applesauce or Via a Nasogastric Feeding Tube With Administration of a Capsule in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This study will be conducted to evaluate the relative bioavailability pharmacokinetics safety and tolerability of AVP-923 dextromethorphan hydrobromide DM and quinidine sulfate Q capsules when the contents of a capsule are administered in applesauce or via a nasogastric feeding tube compared with administration of a capsule in healthy fasting adult participants
Detailed Description:
This is an open-label single-center randomized single-dose 3-treatment 3-period 6-sequence crossover study in healthy adult participants consisting of approximately 7 weeks of treatment The study population will be limited to extensive metabolizers of cytochrome P450 CYP 2D6
Approximately 18 participants will be randomly assigned to 1 of 6 sequences ABC ACB BAC BCA CAB CBA
Approximately 18 participants will be randomly assigned to 1 of 6 sequences ABC ACB BAC BCA CAB CBA
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None