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

March 21, 2023 updated by: Beijing Tongren Hospital

Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets and Calcium Hydroxybenzene Sulfonate Tablets (Doxium®) Under Fed Conditions in Chinese Healthy Volunteers

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The trial preparation is Calcium Hydroxybenzene Sulphonate Dispersible Tablets produced by Hainan Linheng Pharmaceutical Co., Ltd.

The reference preparation is Calcium Hydroxybenzene Sulphonate Tablets (Doxium ®) produced by OM pharma S.A.

The bioequivalence of two preparations will be evaluated at the fast or fed conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Feng Wu, Dr
  • Phone Number: 0086-10-58268486
  • Email: trdrug@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • National Institue for Drug Clinical Trials
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participate voluntarily and sign an informed consent form before the study;
  2. Age: 18 to 55 years old (including 18 and 55 years old) , male and female;
  3. Weight: female subjects with weight ≥45.0kg, male subjects with weight ≥50.0kg, with the body mass index of 19.0~28.0 kg/m (including 19.0 and 28.0);
  4. The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance;
  5. Have no pregnancy plan and appropriate contraceptive measures during the trial and within 6 months after the last dose.
  6. Be able to communicate well, understand and comply with the requirements of the study.

Exclusion Criteria:

  1. Be allergic, or have a clear history of allergies to trial drugs and excipients;
  2. Have diseases in circulatory system, respiratory system, digestive system, hematologic system, nervous system, immune system, urinary system, endocrine system and mental system, or have medical history of the above-mentioned systems and other diseases that may significantly affect drug absorption, distribution, metabolism and excretion.
  3. Have a history of drug abuse or are positive for urine durg screening;
  4. Pregnant or lactating women, or serum HCG positive for female subjects, or there was a unprotected sex within 2 weeks before screening;
  5. Frequent smokers and alcoholics within the first 3 months (smoking more than 5 cigarettes/day on average, drinking an average of more than 21 units of alcohol per week, 1 unit = 360 mL beer or 45 mL liquor or 150 mL wine), or cannot stop using any tobacco products, or unable to stop alcohol intake during the whole research;
  6. Have donated more than 400 mL of blood within 3 months before screening, or lost more than 400 mL of blood for other reasons, or donated plasma within 14 days before screening;
  7. Have used any prescription drugs, vaccines, Chinese herbal medicine within 4 weeks before first dose of the research drug, and/or use any over-the-counter drugs (OTC), vitamins, nutritional supplements within 2 weeks before first dose of the research drug;
  8. Have participated in any clinical trial within 3 months before screening;
  9. Refuse to stop using any methylxanthine drinks or foods such as coffee, tea, cola, chocolate, or drinks containing grapefruit, or any food that affect the activity of liver enzymes from 48 hours before the first dose of the research drug to the end of the study;
  10. Have undergone surgery within 6 months before screening, or plan to receive a surgery recently ;
  11. Have abnormality or clinical significance in any infection screening;
  12. Have special requirements on diet and cannot accept unified diet;
  13. Have the difficulty in venous blood taking or can not tolerate venipuncture, or have a history of dizziness in blood taking;
  14. Any other condition that researchers believe unsuitable for enrolling into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Calcium Hydroxybenzene Sulphonate Dispersible Tablets
The healthy subjects will be administered a single dose of Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g under fast or fed conditions.
Drug: Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g
A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd.
Active Comparator: Doxium®
The healthy subjects will be administered a single dose of Doxium® 250mg under fast or fed conditions.
Drug: Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg
Calcium Hydroxybenzene Sulfonate Tablets（Doxium®）produced by OM pharma S.A.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bioequivalence based on Cmax
Time Frame: Pharmacokinetic plasma samples collected over 36 hour period
Cmax - Maximum Observed Concentration in Plasma
Pharmacokinetic plasma samples collected over 36 hour period
Bioequivalence based on AUC 0-t
Time Frame: Pharmacokinetic plasma samples collected over 36 hour period
Area Under the Concentration-time Curve From Time Zero to Time of Last
Pharmacokinetic plasma samples collected over 36 hour period
Bioequivalence based on AUC 0-∞
Time Frame: Pharmacokinetic plasma samples collected over 36 hour period
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Pharmacokinetic plasma samples collected over 36 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tongren Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hainan Linheng Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-BE-QBHSGFSP-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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