Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets in Chinese Healthy Volunteers

NCT05794919 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-04-03

No results posted yet for this study

Summary

The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.

Conditions

  • Bioequivalence Study

Interventions

DRUG

Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g

A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd.

DRUG

Calcium Hydroxybenzene Sulfonate Tablets(Doxium®) 250mg

Calcium Hydroxybenzene Sulfonate Tablets(Doxium®)produced by OM pharma S.A.

Sponsors & Collaborators

  • Hainan Linheng Pharmaceutical Co., Ltd.

    collaborator UNKNOWN
  • Beijing Tongren Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2023-04-30
Completion
2023-12-31

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 NCT05794919 on ClinicalTrials.gov