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
Recruiting
Conditions
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
Interventional
Enrollment (Anticipated)
56
Phase
- 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
- Name: Feng Wu, Dr
- Phone Number: 0086-10-58268486
- Email: trdrug@126.com
Study Locations
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Beijing
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Beijing, Beijing, China, 100730
- Recruiting
- National Institue for Drug Clinical Trials
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Contact:
- Feng Wu, Dr
- Phone Number: 0086-10-58268486
- Email: trdrug@126.com
-
-
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
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participate voluntarily and sign an informed consent form before the study;
- Age: 18 to 55 years old (including 18 and 55 years old) , male and female;
- 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);
- The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance;
- Have no pregnancy plan and appropriate contraceptive measures during the trial and within 6 months after the last dose.
- Be able to communicate well, understand and comply with the requirements of the study.
Exclusion Criteria:
- Be allergic, or have a clear history of allergies to trial drugs and excipients;
- 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.
- Have a history of drug abuse or are positive for urine durg screening;
- Pregnant or lactating women, or serum HCG positive for female subjects, or there was a unprotected sex within 2 weeks before screening;
- 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;
- 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;
- 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;
- Have participated in any clinical trial within 3 months before screening;
- 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;
- Have undergone surgery within 6 months before screening, or plan to receive a surgery recently ;
- Have abnormality or clinical significance in any infection screening;
- Have special requirements on diet and cannot accept unified diet;
- Have the difficulty in venous blood taking or can not tolerate venipuncture, or have a history of dizziness in blood taking;
- 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 |
Intervention / Treatment |
|---|---|
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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.
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A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd.
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|
Active Comparator: Doxium®
The healthy subjects will be administered a single dose of Doxium® 250mg under fast or fed conditions.
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Calcium Hydroxybenzene Sulfonate Tablets（Doxium®）produced by OM pharma S.A.
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What is the study measuring?
Primary Outcome Measures
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
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Pharmacokinetic plasma samples collected over 36 hour period
|
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
March 20, 2023
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
March 21, 2023
First Submitted That Met QC Criteria
March 21, 2023
First Posted (Actual)
April 3, 2023
Study Record Updates
Last Update Posted (Actual)
April 3, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.