Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509743
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2007-07-27
Brief Title:
Study to Assess Effects of Age Weight and Body Composition on the Pharmacokinetics of IV Diclofenac Sodium
Sponsor:
Javelin Pharmaceuticals
Organization:
Javelin Pharmaceuticals
Study Overview
Official Title:
An Open-Label Single-Dose Study to Assess the Effects of Age Weight and Body Composition on the Pharmacokinetic Profile Safety and Tolerability of Intravenous Diclofenac Sodium DIC075V in Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2009-02
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:
DFC-PK-008
Brief Summary:
The purpose of this study is to assess the effects of age weight and body composition on the pharmacokinetic profile safety and tolerability of intravenous diclofenac sodium DIC075V in adult volunteers
Detailed Description:
This study is an open label single center single-dose study to assess the effects of age weight and body composition on the pharmacokinetic profile safety and tolerability of intravenous diclofenac sodium DIC075V in adult volunteers This study will be conducted in two cohorts The first cohort of subjects will be selected based on body mass index BMI and weight criteria The second cohort of subjects will be selected based on age
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