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RegisterFailed Fed study on Indapamide MR [Study Assessment]
posted by Clarc 
– Romania, 2013-11-20 11:59 (4190 d 21:45 ago) – Posting: # 11925
Views: 10,191
❝ a) what was the Tmax observed for fasting and fed study (for test and reference both)? Was there a wide differene?
In FED state:
Tmax (mean) - Test: 9.8846 / Reference: 7.5385In Fasting:
Tmax (mean) - Test: 14.308 / Reference: 13.962❝ b) Is there any plan to re-do the fasting study again?
As far as I know, the answer is NO.
❝ c) ... Does your formulation has any release controlling excipient which shows food effect? And What is the release mechanism (through erosion and/or diffusion or any other mechanism?)
Yes it has, HPMC. The release mechanism is mostly erosion, but diffusion is implied too.
❝ d) Can you also let us know the time points used in the stduy? Since you AUC inf is higher ~138%, so there might be some issue related to the sampling time points (Kel not measured properly).
Blood samples had been harvested:
pre-dose (0.0) and 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 14.0, 16.0, 24.0, 36.0, 48.0, and 72.0 hours❝ e) Was there any period effect? I know it is long shot but still it could give you some idea for AUC inf if there is a difference in Kel observed in different periods.
The calculated period effect for Cmax was:
0.717 (NS)Clarc
I'm always tryin' to do something new, tryin' to look like a beginner.
Meshell Ndegeocello
Complete thread:
- Failed Fed study on Indapamide MR Clarc 2013-11-19 11:04
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- Failed Fed study on Indapamide MR Dr_Dan 2013-11-19 14:31
- Failed Fed study on Indapamide MR ElMaestro 2013-11-19 15:56
- CV from CI Helmut 2013-11-19 16:42
- CV from CI ElMaestro 2013-11-19 16:59
- Misprint gremlin Helmut 2013-11-19 17:05
- CV from CI ElMaestro 2013-11-19 16:59
- Failed Fed study on Indapamide MR Clarc 2013-11-20 07:28
- CV from CI Helmut 2013-11-19 16:42
- Failed Fed study on Indapamide MR jag009 2013-11-19 19:45
- Failed Fed study on Indapamide MR Clarc 2013-11-20 07:36
- Failed Fed study on Indapamide MR luvblooms 2013-11-20 08:51
- Failed Fed study on Indapamide MRClarc 2013-11-20 10:59
- Failed Fed study on Indapamide MR jag009 2013-11-20 17:30
- Failed Fed study on Indapamide MR luvblooms 2013-11-21 06:00
- Failed Fed study on Indapamide MR Clarc 2013-11-21 07:11
- Failed Fed study on Indapamide MRClarc 2013-11-20 10:59
- Failed Fed study on Indapamide MR luvblooms 2013-11-20 08:51
- Failed Fed study on Indapamide MR Clarc 2013-11-20 07:36
Ing. Helmut Schütz