BE study for Medroxyprogesterone Acetate Injection [Study Per­for­mance]

posted by ramesh_7779  – 2011-01-18 10:56 (5637 d 18:38 ago) – Posting: # 6439
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Dear All,

Can anyone clarify my doubt

Is it necessary to conduct bioequivalence study for Medroxyprogesterone Acetate Injection 150 mg/mL in Postmenopausal Women.
(or)
It can be conducted in healthy female volunteer.
(or)
It can be conducted in healthy male volunteer.

http://clinicaltrials.gov/ct2/show/NCT00381251

As the terminal half life of the drug is 50 days, how long one should collect the blood samples.

Thanks & Regards
Ramesh

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