Bioequivalence and Bioavailability Forum

Dear Forum Members,
Greetings of the Day...!

Amoxicillin powder for suspension is available in two strengths, 125 mg/5ml and 250 mg/5ml in Canada (PrAPO-AMOXI).

As per FDA PSG, Single-dose, two-treatment, two-period crossover in vivo study with 250 mg/5 mL in fasting condition is sufficient for ANDA submission.

But as per the product monograph of PrAPO-AMOXI, for 125 mg/5ml strength BE study was conducted with 10ml as single dose (250 mg/10 mL dose administered) in fasting condition and reported.

For 250 mg/5ml strength BE study was conducted with 5 ml as single dose (250 mg/5 mL dose administered) in fasting condition and reported.

We want to do the Amoxicillin powder for suspension 125 mg/5ml and 250 mg/5ml BE studies for Canada market. We are clear for 250 mg/5ml BE study with 250 mg/5ml dose in fasting condition.

But for 125mg/5mL BE study how much dose to be administered? Can we do study with 5mL of 125mg/5mL test dosing versus 5mL of 125mg/5mL reference dosing? or 10mL of 125mg/5mL test dosing versus 10mL of 125mg/5mL reference dosing. Kindly suggest.

for reference: https://pdf.hres.ca/dpd_pm/00083793.PDF

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Any expert in Canadian regulatory market, please provide your valuable suggestions.

Thank you.

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Edit: Last sentence added from a later (now deleted) post. You can edit your original post for 24 hours. [Helmut]