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RECRUITING
NCT07756996
PHASE1

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

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2026-07-15

Completion Date

2026-10-31

Last Updated

2026-08-11

Healthy Volunteers

Yes

Interventions

DRUG

Ammoxetine hydrochloride Enteric-coated Tablets(new formulation)

oral administration.

DRUG

Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)

oral administration.

Locations (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, China