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I have an issue from a BA/BE study. Buprenorphine Cmax Reported value at 8mg Sublingual tablet single dose from literature (in opioid dependent subjects) is around 3ng/mL. Same value after 7 day multiple dosing varies between 6-12ng/mL. But in my data of 50 healthy volunteers, the Cmax after single dose is coming 5-8(SD=1-4)ng/mL. The same is for reference also. The design used is almost standard like:
1. Keeping SL tablet under tounge until dissolved completely
2. 2 period, 2 sequence, 2 treatment crossover with a washout of 15 days
Intrasubject variability was 20-25%. Can this elevation in Cmax (also AUC0-t) be possible due to use of healthy volunteers?
Please give your suggestions.
-- RAVI KANT BHATIA
Clinsys Clinical Research Ltd.
C-46, Sec-62, Noida
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