Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247488
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
Abuse Potential of HORIZANT With and Without Oxycodone in Healthy Nondependent Recreational Opioid Users
Sponsor:
Azurity Pharmaceuticals
Organization:
Azurity Pharmaceuticals
Study Overview
Official Title:
Randomized Double-blind Active Placebo-controlled 6-way Crossover Study of Abuse Potential of Oral Gabapentin Enacarbil IR Capsules With and Without Oxycodone in Healthy Nondependent Recreational Opioid Users
Status:
COMPLETED
Status Verified Date:
2024-08
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 purpose of this study is to assess the abuse potential of gabapentin enacarbil immediate release capsules taken alone and in combination with oxycodone in healthy adult non-dependent recreational opioid users
Detailed Description:
The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil immediate-release GE-IR the active moiety in Horizant taken alone and taken in combination with oxycodone compared to that of oxycodone alone
This study is a randomized double-blind active- and placebo-controlled 6-way crossover design aimed to assess the abuse potential safety and pharmacokinetics PK of GE-IR doses when administered alone or in combination with an opioid active control oxycodone and compared to placebo and oxycodone intake alone in healthy nondependent recreational opioid users
This study is a randomized double-blind active- and placebo-controlled 6-way crossover design aimed to assess the abuse potential safety and pharmacokinetics PK of GE-IR doses when administered alone or in combination with an opioid active control oxycodone and compared to placebo and oxycodone intake alone in healthy nondependent recreational opioid users
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