Zero Data in Suppositories BE Test [Study As­sess­ment]

posted by Siswanto – Indonesia, 2023-08-15 04:18 (336 d 00:44 ago) – Posting: # 23695
Views: 1,673

Dear Divyen,
Thank you for your reply.

Single dose of the study drug (equivalent to one suppository), either test or reference according to the randomization code will be administered by Responsible Physician or Study Nurse to the subjects in a lateral position. Then, subjects will be asked to maintain in supine position for at least 4 hours and will be monitored by the study team. If there is any subject who needs to go to the toilet during the time range, subject needs to report to study team and study team will record the time and subject’s purpose (urinate/defecate).


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