Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT00406003
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2006-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects
Status:
COMPLETED
Status Verified Date:
2017-09
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 study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: