NCT07508462

A Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects

A Single-dose, Randomized, Open-label, Three-sequence, Three-period Crossover Clinical Trial to Evaluate the Effect of High-fat and Low-fat Meals on the Pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a single-dose, randomized, open-label, three-sequence, three-period crossover clinical trial to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of ammoxetine hydrochloride enteric-coated tablets in healthy subjects.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Ammoxetine hydrochloride enteric-coated tablets	Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
DRUG	Ammoxetine hydrochloride enteric-coated tablets	Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets
DRUG	Ammoxetine hydrochloride enteric-coated tablets	Single-dose of 60 mg of ammoxetine hydrochloride enteric-coated tablets

Timeline

• Start date: 2024-05-30
• Primary completion: 2024-06-17
• Completion: 2024-08-02
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China