Bioequivalence and Bioavailability Forum

Dear Sir,

As a rule for posting in the forum, I did put my effort to find any similar posts and also regulatory agency websites especially FDA and EMEA, with no fruitful results, before posting the [...] query.

Please guide me in this regard.

Thanks and regards,

Nagashayana

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Edit: Fine; but see also this part of the Policy. [Helmut, Madam]

Dear Nagashayana!

❝ With respect to conduct of BA/BE study with rectal suppositories, is there

❝ any guidance document (from any regulatory agency)?

No particular one I know of.

❝ Also as a part of checking compliance to dosing of medication, for oral

❝ formulation, a mouth check is performed after dosing the volunteer. Is

❝ there any parallel procedure for this while dosing is with rectal

❝ suppository?

A check of the oral cavity is essentially performed to ensure that the volunteer has swallowed the formulation. Some suppositories melt within seconds, what procedure are you thinking of?

❝ If not how to ensure that dosing is done properly?

The suppositories should be administered not by the subjects themselves, but by investigators/study nurses. If the study is performed in both sexes, I would strongly recommend to perform the administration by study personnel of the respective sex per group. That's a quite annoying procedure!

A recommendation from my files:

• Fasting for ten hours.
  
• Defecation one hour prior to administration.
  
• If defecation is not possible, administration of an enema of 200 mL body warm water.
  
• Administration of the suppository by an investigator/study nurse.
  
• Volunteers remain in a supine position for the following two hours.
  
• Further defecation should be avoided for at least XX hours (may even be considered as an exclusion criterion).

Of course you have to know the PK of your drug - especially the absorption window - and adapt the posture / defecation limits (XX hours) accordingly.