Bioequivalence and Bioavailability Forum

A-M-R ☆ Egypt, 2011-03-07 11:10 (5591 d 07:22 ago) Posting: # 6711 Views: 5,546	Bioequivalence for chlordiazepoxide and clidinium bromide [Design Issues] Post reply
	Request I have to done bioequivalence study for both chlordiazepoxide and clidinium bromide, can you help me if there is any reply that forgive me from making this study as there is no clear available data on pharmacokinetics for both active substances, and if must be carried, what is the most suitable design for this study. very thanks Amr hussein Edit: Category changed. [Helmut]

Helmut
★★★

Vienna, Austria,
2011-03-07 14:15
(5591 d 04:18 ago)

@ A-M-R
Posting: # 6712
Views: 4,955

BE (chlordiazepoxide / clidinium)

Post reply

Dear Amr,

if I understood you correctly you were asking how to avoid a bioequivalence study? A biowaiver cannot be granted for combination products - therefore I'm afraid you have to perform an in vivo BE study.

❝ [...] as there is no clear available data on pharmacokinetics for both

❝ active substances...

No?

chlordiazepoxide: t½ 5 - 30 hours (t½ major active metabolite desmethyldiazepam 36 - 300 h (!); minor: temazepam 8 - 20 h, oxazepam 4 - 14 h)
clidinium: t½ ≈20 hours (caution: unreliable data)

❝ [...] what is the most suitable design for this study.

Cross-over, single dose fasting, BE of both parent compounds. If you regulation allows truncated AUC₇₂, fine. Washout based on t½ of chlordiazepoxide.

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Bioequivalence for chlordiazepoxide and clidinium bromide [Design Issues]

BE (chlordiazepoxide / clidinium)