Mei San
☆    

Malaysia,
2015-03-03 06:36
(4136 d 07:54 ago)

Posting: # 14534
Views: 8,307
 

 Orlistat PD Endpoint Determination during BE study [Design Issues]

Dear all,

May I know if anyone has experience on orlistat 120mg BE study before?

Many thanks.

Regards,
Mei San.
Dr_Dan
★★  

Germany,
2015-03-04 10:50
(4135 d 03:40 ago)

@ Mei San
Posting: # 14548
Views: 6,938
 

 Orlistat PD Endpoint Determination during BE study


Kind regards and have a nice day
Dr_Dan
nobody
nothing

2015-03-04 11:39
(4135 d 02:51 ago)

@ Dr_Dan
Posting: # 14549
Views: 6,928
 

 Orlistat PD Endpoint Determination during BE study

...but appears doable, as I found at least one EPAR on such a study. As usual in recent times, no sample size was stated, but as CVintras were provided, apparently between 40 and 50 volunteers were included... Most likely based on one of these infamous (dubious?) pilot studies :-D

Kindest regards, nobody
luvblooms
★★  

India,
2015-03-09 07:44
(4130 d 06:46 ago)

@ nobody
Posting: # 14552
Views: 6,941
 

 Orlistat PD Endpoint Determination during BE study

Done one study on orlistat.

And believe me, it is going to be a tough one!! (main problem was keeping volunteers in the facility for ~45-60 day apart from the faecal collection method). But we did that and failed ;-)

Do check this one too

Pharmacodynamic equivalence of two orlistat capsule formulations in healthy volunteers under fed conditions.

Hope this will help

~A happy Soul~
patilatu
☆    

2015-03-09 08:36
(4130 d 05:54 ago)

@ luvblooms
Posting: # 14553
Views: 6,736
 

 Orlistat PD Endpoint Determination during BE study

Dear All,

❝ Done one study on orlistat.


❝ And believe me, it is going to be a tough one!! (main problem was keeping volunteers in the facility for ~45-60 day apart from the fecal collection method).


Yes, I agree. It is logistically very tough. The volunteer availability is a big issue for such a long period.

regards
Patilatu
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