Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.

Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts. Part 1 is a bioequivalence study with administration 1.5 hours after a high-fat meal, using a randomized, open-label, single-dose, four-period fully replicated design. Part 2 is a food effect study using a single-center, open-label, single-dose, two-period crossover design.

NCT Number	NCT07756996
Lead Sponsor	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions	Healthy Participants
Enrollment	62 participants
Start Date	2026-07-15
Primary Completion	2026-08-31 (estimated)
Study Completion	2026-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-11