Bioequivalence and Bioavailability Forum

Hi Ankur,

first I suggest to see this thread.

❝ If in period-1 of bio-study, out of 36 subjects, 13 subjects withdrawn due to Pharmacokinetic reasons (due to AE of vomiting) but not any serious safety issues;

❝

❝ 1. If power of study reduces to very large extent, study will not pass as per regulatory requirement. Would it be ethical to conduct second period?

IMHO no. You had a drop-out rate of 36% in the first period. That’s a lot! If this continues in the second period you might end up with just 14 eligible subjects. If you planned the study for ~90% power, 14 will give you only ~40%. That’s worse than what you can expect from flipping a coin.
I would the study and consider administering a suitable anti-emetic together with your nasty drug in the next study. See also EMA’s GL:

In rare cases, the use of a concomitant medication is needed for all subjects for […] tolerability reasons (e.g. […] anti-emetics). In that scenario, the risk for a potential interaction or bioanalytical interference affecting the results must be addressed.

❝ 2. If study is to be terminated, is it required to submit termination report to DCGI? And if study for US regulatory, is it required to submit termination report to USFDA?

No idea; but I would guess so.

Dear Mr Anky1212,

❝ 2. If study is to be terminated, is it required to submit termination report to DCGI?

Yes. The study termination report need to be submitted to DCGI along with the complete details and reasons for study termination.