Bioequivalence and Bioavailability Forum

Dear All,

We are developing clomipramine capsule 10mg, 25mg & 50mg formulation to compare with Anafranil (clomipramine) tablets 10mg, 25mg & 50mg.

I have few doubts over strength(s) to be investigated.

Anafranil (reference) 10 mg and 25 mg tablets are sugar coated and 50 mg tablets are film coated. Composition of 50 mg tablets contains surfactant whereas 10 mg and 25 mg does not contains any surfactant. Invitro release is slower for 10 & 25 mg Anafranil compared to 50 mg of Anafranil.

Compsoition of test formulation will be qualitatively same and quantitatively proportional.

Clomipramine follows linear PK over the dose range of 25 to 150 mg.

1. Is it possible to get waiver for 10 mg & 25 mg capsules with a BE study of 50 mg capsules? or BE required for all the strengths?
   
   
2. As per SPC the initial adult dose is 10mg/day and dose may be increased gradually. In this case, can 50mg be dosed in BE study?

Best Regards,
Sanjeith K

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Edit: Category changed; see also this post #1. [Helmut]