NCT05072535

A Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects

A Single-dose, Randomized, Open-label, Two-period Crossover, Phase I Study to Evaluate Relative Bioavailability and Food-Effect of HA121-28 Tablet B in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study will be divided into 2 parts. The first part is a relative bioavailability study of HA121-28 tablet A and HA121-28 tablet B, and the second part is a food effect study of HA121-28 tablet B. Both Parts are single-dose, randomized, open-label, two-period crossover study to evaluate relative bioavailability HA121-28 tablet B in healthy subjects and the effect of food on pharmacokinetic profile of HA121-28 tablet B, respectively.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HA121-28 tablet B	HA121-28 tablet B 200 mg
DRUG	HA121-28 tablet A	HA121-28 tablet A 200 mg

Timeline

• Start date: 2021-10-08
• Primary completion: 2021-12-19
• Completion: 2022-03-03
• First posted: 2021-10-11
• Last updated: 2022-03-14

Locations

1 site across 1 country: China