BioequivalencePhase 1NCT06066112
Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets in Human Body
A Phase 1 study testing Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd. in people with Bioequivalence and Schizophrenia, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence, Schizophrenia
- What is being tested?
- Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 31 Mar 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Chinese male or female subjects aged ≥ 18 years old (including 18 years old);
- 2. Weight: Male ≥ 50 kg, female ≥ 45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values, BMI=weight (kg)/height 2 (m2));
- 3. During the screening period, the vital signs, physical examination, laboratory examination, and electrocardiogram of the subjects were found to be normal or abnormal, and were determined by the researchers to be clinically insignificant;
- 4. All fertile subjects agree to take appropriate and effective physical contraception measures for themselves and their partners from the screening period (female subjects from 2 weeks before screening) to the end of the experiment, and to take effective physical contraception and/or medication contraception measures within 6 months after the end of the experiment, without any plans for sperm or egg donation;
- 5. The subjects fully understand the purpose, nature, and potential adverse reactions of the experiment, understand and follow the research process, voluntarily participate, and sign an informed consent form;
- 6. Those who are able to communicate well with researchers and understand and comply with the requirements of this study.
Who cannot join
- 1. Those with a past or existing history of the following diseases or chronic/severe illnesses, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for subjects with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect drug absorption, distribution, metabolism, and excretion;
- 2. Screening subjects who have undergone surgery within the first 3 months, or who plan to undergo surgery during the study period, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion;
- 3. There is a history of food and drug allergies that researchers have determined to be clinically significant; Or known allergies to sulfamethoxide or its excipients, or a history of other allergic diseases (asthma, urticaria, eczema dermatitis);
- 4. Previous or existing history of vascular edema or peripheral edema;
- 5. Screening for individuals with blurred vision, visual abnormalities, diplopia, or fundus lesions within the first 14 days; 6. Individuals with oral diseases such as oral ulcers during the screening period;
- 7. Previous or existing xerostomia patients;
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- 8. People with positive results of any test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody (TP Ab);
- 9. Screening for individuals with a history of drug abuse or positive urine drug abuse screening within the previous 12 months;
- 10. Regular drinkers within the first 6 months of screening, i.e. those who consume an average of more than 14 units of alcohol per week (1 unit ≈ 285 mL of beer with an alcohol content of 3.5%, 25 mL of spirits with an alcohol content of 40%, or 85 mL of wine with an alcohol content of 12%), or those who cannot dispose of alcohol 48 hours before administration until the end of the study, or those who have tested positive for alcohol breath during the screening period; 11. Smoking an average of more than 5 cigarettes per day in the first 3 months of screening; Or those who cannot give up smoking 48 hours before administration until the end of the study;
- 12. Receive blood transfusion or use blood products within 3 months before screening; Those who have donated blood or experienced significant bleeding (greater than 400 mL, except for blood loss during normal physiological periods in females) within 3 months before the first administration, or plan to donate blood or blood components during the study period or within 1 week after the end of the study;
- 13. Screening subjects who have participated or are currently participating in other clinical trials within the first 3 months (drug clinical trials are defined as those who have used clinical research drugs);
- 14. Screening subjects who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, and functional vitamins within the previous 14 days; Or those who have received vaccines within 2 weeks before screening or those who have vaccination plans during the trial period;
- 15. Those who have special dietary requirements, cannot accept a unified diet, and comply with corresponding regulations; Or those who consume beverages (coffee, tea) or food (animal liver) rich in xanthine during the experiment, or consume fruits or juice such as grapefruit, grapefruit, mango, etc. that may affect drug metabolism;
- 16. Individuals with rare genetic diseases such as lactose or galactose intolerance, primary lactase deficiency, or glucose galactose malabsorption; 17. Pregnant or lactating female subjects; Female reproductive age subjects who engage in sexual activity without effective contraceptive measures within 14 days prior to signing the informed consent form;
- 18. Those with difficulty swallowing;
- 19. Patients with poor vascular puncture conditions, inability to tolerate venous puncture, or those with needle and blood fainting;
- 20. Other subjects deemed unsuitable by the researchers to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University Phase I Clinical Research Center
Qingdao, Shandong, 266000
Yu Cao, 18661809090, caoyu1767@126.com
About this study
Official title: Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets (200 mg) in Chinese Healthy Subjects Under Single Dose, Randomized, Open, Two Formulation, Two Sequence, Two Cycle, Double Crossover, Fasting, and Postprandial Conditions
The experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.
- Conditions
- Bioequivalence, Schizophrenia
- Being tested
- Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.
- Keywords
- amisulpride orally disintegrating tablets
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.Drug
Also called Reference (R) Amisulpride tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.
Randomly assign to TR or RT sequence groups based on a predetermined random table and receive the corresponding study drug according to the corresponding administration sequence.
| Study group | Role | What they receive |
|---|---|---|
| Fasting state | Experimental | The subjects fasted overnight for at least 10 hours, and an indwelling needle was buried before administration. On the morning of administration, one test formulation (T) or one control formulation (R) was administered on an empty stomach, and the start time of administration was recorded. After administration, the oral cavity and medication container should be checked to ensure the correct use of the medication. Do not drink water from 1 hour before medication to 1 hour after medication (except for 20ml of water moistened with the test formulation and 240 mL of water from the control formulation). Control drinking water from 1 hour to 4 hours after medication, and drink freely at other times. Fasting within 4 hours after medication. After medication, keep the upper body upright for 4 hours. The meal time on the day of the two cycles of medication is roughly the same. Receives: Drug: Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd. |
| Fed state | Experimental | Before administration, subjects were placed with an indwelling needle and fasted overnight for at least 10 hours before consuming a high-fat meal. They started eating a high-fat meal 30 minutes before taking the medication on the morning of the day of administration. Control drinking water from 1 hour to 4 hours after taking the medication, and drink freely at other times. Fasting within 4 hours after taking the medication. After medication, keep the upper body upright for 4 hours. The meal time on the day of the two cycles of medication is roughly the same. Receives: Drug: Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Measured: 48 hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start20 Sep 2023
- Primary completion7 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066112
- Sponsor's protocol ID
- HQ-0124-BE01
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Bioequivalence of Amisulpride Orally Disintegrating Tablets (200 mg) in Chinese Healthy Subjects Under Single Dose, Randomized, Open, Two Formulation, Two Sequence, Two Cycle, Double Crossover, Fasting, and Postprandial Conditions
- ClinicalTrials.gov ID
- NCT06066112
- Acronym / sponsor ID
- HQ-0124-BE01
- Conditions
- Bioequivalence, Schizophrenia
- Keywords
- amisulpride orally disintegrating tablets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 7 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 4 Oct 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 experiment adopts a single center, randomized, open, single dose, two cycle, and double crossover design. The subjects were randomly divided into TR and RT groups. In the first cycle, they received the test or control formulation on an empty stomach or after a meal. After a cleaning period, they entered the second cycle and received the control or test formulation in the same state. The cleaning period between the two cycles was 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting state | Experimental | Drug: Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.The subjects fasted overnight for at least 10 hours, and an indwelling needle was buried before administration. On the morning of administration, one test formulation (T) or one control formulation (R) was administered on an empty stomach, and the start time of administration was recorded. After administration, the oral cavity and medication container should be checked to ensure the correct use of the medication. Do not drink water from 1 hour before medication to 1 hour after medication (except for 20ml of water moistened with the test formulation and 240 mL of water from the control formulation). Control drinking water from 1 hour to 4 hours after medication, and drink freely at other times. Fasting within 4 hours after medication. After medication, keep the upper body upright for 4 hours. The meal time on the day of the two cycles of medication is roughly the same. |
| Fed state | Experimental | Drug: Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.Before administration, subjects were placed with an indwelling needle and fasted overnight for at least 10 hours before consuming a high-fat meal. They started eating a high-fat meal 30 minutes before taking the medication on the morning of the day of administration. Control drinking water from 1 hour to 4 hours after taking the medication, and drink freely at other times. Fasting within 4 hours after taking the medication. After medication, keep the upper body upright for 4 hours. The meal time on the day of the two cycles of medication is roughly the same. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Chinese male or female subjects aged ≥ 18 years old (including 18 years old);
- 2. Weight: Male ≥ 50 kg, female ≥ 45 kg, and body mass index (BMI) between 19.0 and 26.0 kg/m2 (including boundary values, BMI=weight (kg)/height 2 (m2));
- 3. During the screening period, the vital signs, physical examination, laboratory examination, and electrocardiogram of the subjects were found to be normal or abnormal, and were determined by the researchers to be clinically insignificant;
- 4. All fertile subjects agree to take appropriate and effective physical contraception measures for themselves and their partners from the screening period (female subjects from 2 weeks before screening) to the end of the experiment, and to take effective physical contraception and/or medication contraception measures within 6 months after the end of the experiment, without any plans for sperm or egg donation;
- 5. The subjects fully understand the purpose, nature, and potential adverse reactions of the experiment, understand and follow the research process, voluntarily participate, and sign an informed consent form;
Key exclusion criteria (17 listed)
- 1. Those with a past or existing history of the following diseases or chronic/severe illnesses, including but not limited to the cardiovascular system, digestive system, urogenital system, respiratory system, blood system, endocrine system, immune system, mental nervous system, skeletal system, etc., that researchers believe are still clinically significant; Especially for subjects with gastrointestinal dysfunction, peptic ulcer, gastrointestinal surgery, and other diseases that affect drug absorption, distribution, metabolism, and excretion;
- 2. Screening subjects who have undergone surgery within the first 3 months, or who plan to undergo surgery during the study period, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion;
- 3. There is a history of food and drug allergies that researchers have determined to be clinically significant; Or known allergies to sulfamethoxide or its excipients, or a history of other allergic diseases (asthma, urticaria, eczema dermatitis);
- 4. Previous or existing history of vascular edema or peripheral edema;
- 5. Screening for individuals with blurred vision, visual abnormalities, diplopia, or fundus lesions within the first 14 days; 6. Individuals with oral diseases such as oral ulcers during the screening period;
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 |
|---|---|---|
| Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.Also: Reference (R) Amisulpride tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd.Randomly assign to TR or RT sequence groups based on a predetermined random table and receive the corresponding study drug according to the corresponding administration sequence. | Drug | Fasting state, Fed state |
Primary outcome
Cmax
Time frame: 48 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 48 hours
Area under the drug concentration-time curve from time 0 to the last accurately measurable concentration at sample collection time t
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 48 hours
Area Under the Plasma Drug Concentration-Time Curve from Time 0 to Infinite Time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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 Phase 1 study testing Drug: Test (T) Amisulpride orally disintegrating tablets (200mg). Produced and supplied by Zezheng (Shanghai) Biotechnology Co., Ltd. in people with Bioequivalence and Schizophrenia, run by The Affiliated Hospital of Qingdao University 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 17 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 4 Oct 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yu Cao (18661809090, caoyu1767@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 48 hours). 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 4 Oct 2023.