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

NCT05072535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-14

No results posted yet for this study

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

DRUG

HA121-28 tablet B

HA121-28 tablet B 200 mg

DRUG

HA121-28 tablet A

HA121-28 tablet A 200 mg

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2021-12-19
Completion
2022-03-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05072535 on ClinicalTrials.gov