Bioequivalence and Bioavailability Forum

Dear All,

Can anyone please let me know whether the below mentioned objective can be carried in healthy volunteers.

Objectives:

1. Need to perform efficacy comparisons between Two topical Gel and one Oral (Tablet) formulation -It is a three arm study Can it be performed?

2. Need to conduct Pharmacokinetics evaluation between one Topical and one Oral formulation.

If yes, IS it is a regular three period, three way cross over study? or we can go for a parallel design?

Can both objective 1 and 2 can be carried out in a single study?

Are there any guidance in FDA?

Regards,

S.Yogesh