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Bioequivalence Test of Hemay005 Tablets

NCT06610903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-03-18

No results posted yet for this study

Summary

The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.

Conditions

Interventions

DRUG

Hemay005

In the first cycle, 15mg (1 tablet/person) was given on an empty stomach for Hemay005-T1 or Hemay005-T2, and the second cycle was crossed over

Sponsors & Collaborators

  • Ganzhou Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2024-09-30
Completion
2025-02-17

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT06610903 on ClinicalTrials.gov