Bioequivalence StudyNCT05794919
Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets in Chinese Healthy Volunteers
A study testing Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g and Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg in people with Bioequivalence Study, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g and Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Institue for Drug Clinical Trials
Beijing, Beijing Municipality, 100730
Feng Wu, Dr, 0086-10-58268486, trdrug@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bioequivalence Study
- Being tested
- Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g, Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25gDrug
A generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd.
Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mgDrug
Calcium Hydroxybenzene Sulfonate Tablets（Doxium®）produced by OM pharma S.A.
| Study group | Role | What they receive |
|---|---|---|
| Calcium Hydroxybenzene Sulphonate Dispersible Tablets | Experimental | The healthy subjects will be administered a single dose of Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g under fast or fed conditions. Receives: Drug: Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g |
| Doxium® | Active comparator | The healthy subjects will be administered a single dose of Doxium® 250mg under fast or fed conditions. Receives: Drug: Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax
Cmax - Maximum Observed Concentration in Plasma
Measured: Pharmacokinetic plasma samples collected over 36 hour period
Bioequivalence based on AUC 0-t
Area Under the Concentration-time Curve From Time Zero to Time of Last
Measured: Pharmacokinetic plasma samples collected over 36 hour period
Bioequivalence based on AUC 0-∞
Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Measured: Pharmacokinetic plasma samples collected over 36 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start20 Mar 2023
- Primary completionApr 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hainan Linheng Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794919
- Sponsor's protocol ID
- 2022-BE-QBHSGFSP-04
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Calcium Hydroxybenzene Sulphonate Dispersible Tablets and Calcium Hydroxybenzene Sulfonate Tablets (Doxium®) Under Fed Conditions in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05794919
- Acronym / sponsor ID
- 2022-BE-QBHSGFSP-04
- Conditions
- Bioequivalence Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Hainan Linheng Pharmaceutical Co., Ltd.
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the bioequivalence of two Calcium Hydroxybenzene Dispersible Tablets in healthy Chinese volunteers.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium Hydroxybenzene Sulphonate Dispersible Tablets | Experimental | Drug: Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25gThe healthy subjects will be administered a single dose of Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g under fast or fed conditions. |
| Doxium® | Active comparator | Drug: Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mgThe healthy subjects will be administered a single dose of Doxium® 250mg under fast or fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25gA generic product manufactured by Hainan Linheng Pharmaceutical Co., Ltd. | Drug | Calcium Hydroxybenzene Sulphonate Dispersible Tablets |
| Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mgCalcium Hydroxybenzene Sulfonate Tablets（Doxium®）produced by OM pharma S.A. | Drug | Doxium® |
Primary outcome
Bioequivalence based on Cmax
Time frame: Pharmacokinetic plasma samples collected over 36 hour period
Cmax - Maximum Observed Concentration in Plasma
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
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxybenzene Sulphonate Dispersible Tablets 0.25g and Calcium Hydroxybenzene Sulfonate Tablets（Doxium®) 250mg in people with Bioequivalence Study, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wu, Dr (0086-10-58268486, trdrug@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax (time frame: Pharmacokinetic plasma samples collected over 36 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.