PsoriasisPhase 1NCT06610903
Bioequivalence Test of Hemay005 Tablets
A Phase 1 study testing Hemay005 in people with Psoriasis, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Hemay005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2024to 17 Feb 2025
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male and female subjects aged from 18 to 65 years old (including 18 and 65 years old), with an appropriate gender ratio;
- body weight: no less than 50.0kg for men, no less than 45.0kg for women, and body mass index (BMI) [= weight (kg)/height 2 (m2)] between 19.0 and 26.0 kg/m2 (including boundary values);
- 90mmHg≤ systolic blood pressure \<140mmHg, 60mmHg≤ diastolic blood pressure \<90 mmHg, 60 BPM ≤ pulse ≤100 BPM, normal body temperature;
- have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent.
Who cannot join
- Participants who participated in clinical trials of other drugs/devices within 3 months and used the investigational drugs/devices;
- (Inquiry) patients with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems;
- (inquiry) the history of vomiting, diarrhea or any physiological condition that could interfere with the test results within 7 days before the test;
- (Enquire) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic to any drug, food or pollen, or known allergic to PDE4 inhibitors (e.g., apemilast, roflumilast, etc.);
- (inquiry) those who have lost blood or donated more than 400mL of blood within 3 months before the trial, or intend to donate blood during the trial;
- (Inquiry) pregnant or lactating women, or subjects (including male subjects) who have fertility or sperm or egg donation plans from 30 days before the study to 6 months after the last dose of the study, and who are unwilling or unable to use effective contraceptive measures;
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- general physical examination and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine, blood/urine pregnancy (female), etc.) within 7 days before the test, and electrocardiogram (ECG) results judged by clinicians as clinically significant within 14 days before the test;
- if one or more of hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or treponema pallidum antibody is clinically significant;
- (inquiry) patients who had a clinically significant major disease or underwent a major surgical operation within 3 months before the trial;
- (inquiry) Subjects who consumed more than 14 units of alcohol per week (1 unit = 17.7 mL ethanol, i.e. 1 unit = 354 mL of 5% beer or 44mL of 40% liquor or 147 mL of 12% wine) in the 3 months before the trial, or who could not abstain from alcohol during the trial;
- (Inquired) smoked more than 5 cigarettes per day in the 3 months before the trial, or could not stop using any tobacco products during the trial;
- (inquiry) consuming excessive amounts of tea, coffee and/or caffeine-rich beverages (\> 8 cups, 1 cup =250 mL) per day in the 3 months before the study;
- (question) consumed any foods or drinks (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) rich in caffeine/xanthine or other special ingredients (such as strong tea, coffee, chocolate, cola, animal organs, grapefruit, dragon fruit, mango, etc.) from screening to -2 days of admission, or could not stop eating the above foods or drinks during the study;
- (inquiry) use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids; Inhibitors (SSRI antidepressants, cimetidine, sedative- hypnotics, verapamil, fluoroquinolones, antihistamines);
- (inquiry) those who are unable to eat or have swallowing difficulties, have special dietary requirements and/or cannot follow a uniform diet;
- (inquirers) with a history of asthma or seizures;
- (inquired) who had used any prescription drugs, over-the-counter drugs, nutricals, herbal products or received vaccines within 14 days before the trial;
- (Inquiry) Mechanical operators who are engaged in high-altitude work, motor vehicle driving and other associated hazards;
- (inquiry) can not tolerate venipuncture and/or have a history of dizziness;
- (asked) who had used any drugs in the year before the test;
- alcohol breath test results \> 0.0mg/100mL or drug abuse screening positive (morphine, methamphetamines, ketamine, dimethylenedioxyamphetamine, tetrahydrocannabinol acid, cocaine);
- subjects who were considered by the investigator to have poor adherence or any factor that precluded participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Protocol for a Single-center, Randomized, Open-label, Two-formulation, Single-dose, Two-cycle, Double-crossover Fasting Bioequivalence Trial of Hemay005 Tablets in Healthy Subjects
The pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.
Read the detailed description
To evaluate the pharmacokinetics and bioequivalence of the test formulation T1 and the control formulation T2 in healthy subjects under fasting state. The safety of the two preparations in vivo was observed
- Conditions
- Psoriasis
- Being tested
- Hemay005
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005Drug
In the first cycle, 15mg (1 tablet/person) was given on an empty stomach for Hemay005-T1 or Hemay005-T2, and the second cycle was crossed over
| Study group | Role | What they receive |
|---|---|---|
| Healthy subject group 1 | Experimental | 15mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8 Receives: Drug: Hemay005 |
| Healthy subject group 2 | Experimental | 15mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8 Receives: Drug: Hemay005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-4，Day8-11
Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-4，Day8-11
Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)
All subjects who receive the drug will be analyzed for pharmacokinetic
Measured: Day1-4，Day8-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Sep 2024
- Primary completion30 Sep 2024
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610903
- Sponsor's protocol ID
- HM005PS1S09
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol for a Single-center, Randomized, Open-label, Two-formulation, Single-dose, Two-cycle, Double-crossover Fasting Bioequivalence Trial of Hemay005 Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06610903
- Acronym / sponsor ID
- HM005PS1S09
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 24 Sep 2024 (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 pharmacokinetics behavior of the test formulation T1 and the control formulation T2 were evaluated by oral administration in healthy subjects under fasting state to evaluate the bioequivalence of the two formulations.
Detailed description
To evaluate the pharmacokinetics and bioequivalence of the test formulation T1 and the control formulation T2 in healthy subjects under fasting state. The safety of the two preparations in vivo was observed
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subject group 1 | Experimental | Drug: Hemay00515mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8 |
| Healthy subject group 2 | Experimental | Drug: Hemay00515mg/tablet，one tablet each time. Participants will receive a single dose of Hemay005 tablet in Day1and Day8 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male and female subjects aged from 18 to 65 years old (including 18 and 65 years old), with an appropriate gender ratio;
- body weight: no less than 50.0kg for men, no less than 45.0kg for women, and body mass index (BMI) [= weight (kg)/height 2 (m2)] between 19.0 and 26.0 kg/m2 (including boundary values);
- 90mmHg≤ systolic blood pressure \<140mmHg, 60mmHg≤ diastolic blood pressure \<90 mmHg, 60 BPM ≤ pulse ≤100 BPM, normal body temperature;
- have understood the nature, significance, possible benefits, possible inconvenience and potential risks of the trial in detail before the trial, and voluntarily participate in the clinical trial, can communicate well with the investigators, comply with the requirements of the whole study, and sign the written informed consent.
Key exclusion criteria (22 listed)
- Participants who participated in clinical trials of other drugs/devices within 3 months and used the investigational drugs/devices;
- (Inquiry) patients with abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolic system, skeletal system and other systems;
- (inquiry) the history of vomiting, diarrhea or any physiological condition that could interfere with the test results within 7 days before the test;
- (Enquire) patients with specific allergic history (asthma, urticaria, eczema, etc.), or allergic to any drug, food or pollen, or known allergic to PDE4 inhibitors (e.g., apemilast, roflumilast, etc.);
- (inquiry) those who have lost blood or donated more than 400mL of blood within 3 months before the trial, or intend to donate blood during the trial;
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 |
|---|---|---|
| Hemay005In the first cycle, 15mg (1 tablet/person) was given on an empty stomach for Hemay005-T1 or Hemay005-T2, and the second cycle was crossed over | Drug | Healthy subject group 1, Healthy subject group 2 |
Primary outcome
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）
Time frame: Day1-4，Day8-11
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）
Time frame: Day1-4，Day8-11
All subjects who receive the drug will be analyzed for pharmacokinetic
Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)
Time frame: Day1-4，Day8-11
All subjects who receive the drug will be analyzed for pharmacokinetic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemay005 in people with Psoriasis, run by Ganzhou Hemay Pharmaceutical Co., Ltd 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 4 inclusion and 22 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: finished, as of the sponsor's last update on 18 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax） (time frame: Day1-4，Day8-11). 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 18 Mar 2025.