Bioequivalence and Bioavailability Forum

Hi Raghu,
remember bioequivalence study is performed in same strength, hence you dose (3 x 6= 18 mg) three tablets of reference at time which is equivalent to the test product strenth i.e. 18 mg.
if you administered reference product Thrice In a Day then each of Cmax will be at different time then how will you show the equivalence with test Cmax.

regards.
Santosh A.

Dear Raghu!

❝ we want to show the Bioequivalence by Comparing the one dose of 18 mg Extended release tablet (Test) with that of Three doses of 6 mg immediate release tablet (Reference)?

Keeping terminology up: it's not possible to show bioequivalence of an MR formulation to an IR formulation (rate is intended to be different).
Ask yourself what's the rationale for developing such an MR formulation. Probably you want to improve compliance - one dose of 18 mg in the morning instead of 3 single doses throughout the day. Another possibility would be lower fluctuations in steady state.

❝ For this, do i have to administer the reference product Thrice In a Day or three reference tablets at single time

See for example EMEA's guideline (Appendix 1) for the studies to be performed.
You should administer the IR formulation according to it's label: the dosage interval for some antibiotics is strictly 8 hours; if the label only states three times a day, dosage intervals of 6/6/12 hours (morning, afternoon, evening) may be more appropriate.