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AngusMcLean ★★ USA, 2014-05-06 01:51 (4430 d 22:36 ago) Posting: # 12915 Views: 4,487 |
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Usually when studying a food effect the study is performed as a two way crossover study in the morning (fed v fasted). If the study drug formulation under examination is given in the evening then in the same way the food can be given in the evening and also crossed over with the fasted state in the evening. I have an interest in study design precedence, where for an MR formulation: (a) the MR formulation is given in the evening fasted and in the morning at~ 8 am there is a high fat breakfast. Compared with (b) the MR formulation is given in the evening fasted and in the morning at ~ 8 am there is no breakfast. The idea is to investigate the influence of fed/fasted status in the morning on the bio availability of a MR formulation given the previous evening. Drugs that can be administered in the evening that come to mind are verapamil and diltiazem, but of course there are many others. I am looking for such studies and published results. Angus |
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jag009 ★★★ NJ, 2014-05-07 22:48 (4429 d 01:39 ago) @ AngusMcLean Posting: # 12924 Views: 3,585 |
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❝ Usually when studying a food effect the study is performed as a two way crossover study in the morning (fed v fasted). If the study drug formulation … Evening as in 8pM fasted and then give breakfast at 8am in the morning? That is 12 hours. I doubt you will see a difference between fast & fed (but I could be wrong). I have done nighttime dosing study for a product to be dose in the evening but the food effect study for that submission was a regular 2-way food effect (fast vs fed) study. John |
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AngusMcLean ★★ USA, 2014-05-08 01:45 (4428 d 22:42 ago) @ jag009 Posting: # 12925 Views: 3,539 |
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John: Thanks for your remarks. My interest is in example of the study I give being done to evaluate morning food effect in morning following fasted administration at 8-9pm. So far I have not found an example in literature. Angus |
Ing. Helmut Schütz