BioequivalencePhase 1NCT06164431
Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273
A Phase 1 study testing ZSP1273 tablet and zsp1273 granules in people with Bioequivalence, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions. Bioavailability will be evaluated and verified on the basis of pharmacokinetic data. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- ZSP1273 tablet and zsp1273 granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 22 Dec 2023
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
Who cannot join
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
- Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
- Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
- Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
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- Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History of dysphagia or any gastrointestinal disorder that affect absorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants
The purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
- Conditions
- Bioequivalence
- Being tested
- ZSP1273 tablet, zsp1273 granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273 tabletDrug
Participants receive ZSP1273 tablet orally.
zsp1273 granulesDrug
Participants receive ZSP1273 granules orally.
| Study group | Role | What they receive |
|---|---|---|
| ZSP1273 Sequence 1 | Experimental | Single oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period. Receives: Drug: ZSP1273 tablet; Drug: zsp1273 granules |
| ZSP1273 Sequence 2 | Experimental | Single oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period. Receives: Drug: ZSP1273 tablet; Drug: zsp1273 granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Measured: Day 1 to Day 20
Area under the concentration-time curve from time zero to infinity (AUCinf)
The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Measured: Day 1 to Day 20
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Measured: Day 1 to Day 20
Secondary outcomes (1)
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Measured: Day 1 to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start23 Nov 2023
- Primary completion15 Dec 2023
- Study completion22 Dec 2023
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164431
- Sponsor's protocol ID
- ZSP1273-22-09
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose, Open-label, Randomized, Crossover Bioavailability Study of 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 Under Fasted Condition in Healthy Participants
- ClinicalTrials.gov ID
- NCT06164431
- Acronym / sponsor ID
- ZSP1273-22-09
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 11 Dec 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 purpose of this study is to establish bioavailability of 2 treatments with ZSP1273: 200mg tablets and 200mg granules will be given to healthy Participants under fasting conditions.
Bioavailability will be evaluated and verified on the basis of pharmacokinetic data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZSP1273 Sequence 1 | Experimental | Drug: ZSP1273 tablet, Drug: zsp1273 granulesSingle oral dose of 200mg ZSP1273 tablet administered under fasting conditions in first period and 200mg granules in second period，then 200mg ZSP1273 tablet administered under fasting conditions in third period and 200mg granules in fourth period. |
| ZSP1273 Sequence 2 | Experimental | Drug: ZSP1273 tablet, Drug: zsp1273 granulesSingle oral dose of 200mg ZSP1273 granules administered under fasting conditions in first period and 200mg tablet in second period，then 200mg ZSP1273 granules administered under fasting conditions in third period and 200mg tablet in fourth period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, and clinical laboratory values, or any abnormality that is non-clinically significant.
Key exclusion criteria (9 listed)
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.
- Participants had taken prescription, over-the-counter, herbal, or vitamin products within 14 days prior to screening；
- Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
- Those with clinically significant Electrocardiogram(ECG) abnormalities, or QTcF > 450ms;
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 |
|---|---|---|
| ZSP1273 tabletParticipants receive ZSP1273 tablet orally. | Drug | ZSP1273 Sequence 1, ZSP1273 Sequence 2 |
| zsp1273 granulesParticipants receive ZSP1273 granules orally. | Drug | ZSP1273 Sequence 1, ZSP1273 Sequence 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 to Day 20
The Cmax of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Area under the concentration-time curve from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 20
The AUCinf of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)
Time frame: Day 1 to Day 20
The AUClast of a single dose of ZSP1273 tablet and ZSP1273 granules will be evaluated and compared.
1 secondary outcome
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day 20
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 29 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 ZSP1273 tablet and zsp1273 granules in people with Bioequivalence, run by Guangdong Raynovent Biotech 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 3 inclusion and 9 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 29 Jan 2024. 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?
Maximum observed plasma concentration (Cmax) (time frame: Day 1 to Day 20). 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 29 Jan 2024.