Bioequivalence and Bioavailability Forum • Promazine hydrochloride Pharmacokinetics

Promazine hydrochloride Pharmacokinetics [Design Issues]

posted by pjs – India, 2015-05-13 13:51 (3596 d 03:36 ago) – Posting: # 14800
Views: 10,960

Dear all,

❝ Please suggest the innovator for Promazine hydrochloride in EMEA. We are developing two strengths 50mg and 25mg.

Wyeth pharma is the innovator for Promazine IN US (Approved in 1957 discontinued in 1997). IN EMEA couldnt find the active marketing status of innovator in any country. Yet generic tab were aprroved in 2015 (Is innovator tablet still available in the market or bibliographic application?).

❝ Also suggest about the pharmacokinetic linearity and intra subject variability of Promazine.

Have searched several times couldnt find a single BE study or linearity information. Promazine is reported to be highly variable after oral administration but no information regarding intrasubject CV.

One literature suggested dose proportional increase in urinary elimination after oral administration in the dose range. Promazine is highly permiable and soluble (BCS class 1). However no specific mention of pharmacokinetic linearity is there.

Regards,
PJS

Complete thread:

Promazine hydrochloride Pharmacokinetics pjs 2015-05-13 05:45 [Design Issues]
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