Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02447601
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2015-03-25
Brief Title:
Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
An Open-labelSequentialSingle-site Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Polyethylene Glycol Loxenatide PEX168 in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2015-05
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:
To assess the effect of PEX168 doses on the pharmacokinetics of simvastatinas determined by simvastation acid in healthy subjects
To assess the safety of single doses of simvastation administered with and without PEX168
To assess the safety of single doses of simvastation administered with and without PEX168
Detailed Description:
This was an open-label sequential single-center study that evaluated the pharmacokinetics of simvastatin when coadministered with PEX168 in healthy adult subjects The total duration of each subjects participation in the study was approximately 10 weeks which included up to a 14-day Screening Period a 34-day Treatment Period and an approximately 4-week Follow-up Period
Center This study was conducted at a single site in Shanghai Mental Health Center SMHCof China TreatmentAll subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33
Center This study was conducted at a single site in Shanghai Mental Health Center SMHCof China TreatmentAll subjects receives a single 40-mg oral dose of simvastatin on Day 1 followed by 5 weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 3 and a second single 40-mg oral dose of simvastatin on Day 33
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PEX168-Ik | OTHER | JiangsuHaosen | None |