Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-20 @ 10:09 PM
Study NCT ID:
NCT02192151
Status:
TERMINATED
Last Update Posted:
2025-06-06
First Post:
2013-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of PHN131 in Healthy Volunteers
Sponsor:
PhytoHealth Corporation
Organization:
Study Overview
Official Title:
The Pharmacokinetic and Bioavailability Studies of PHN131, an Oral Formulation of Nalbuphine Hydrochloride, in Healthy Volunteers
Status:
TERMINATED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
CSR completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and to investigate the pharmacokinetic properties and bioavailability of PHN131 in healthy volunteers
Detailed Description:
1. Efficacy endpoint(s): the pharmacokinetic properties and bioavailability of PHN131 The efficacy endpoint will be the pharmacokinetic properties after administered PHN131 such as the concentration of nalbuphine in plasma and pharmacokinetic parameters of PHN131 analyzed from the concentration of nalbuphine in plasma. The bioavailability of PHN131 will be calculated from the pharmacokinetic parameters of PHN131 and Nubain® injection.
2. Safety evaluation:
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
2. Safety evaluation:
The safety evaluation will include the vital signs monitoring such as blood pressure, pulse rate, body temperature and respiratory rate in the treatment period.
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?: