Healthy ParticipantsPhase 1NCT06678542
Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects
A Phase 1 study testing GP681 tablet and GP681 Powder for Oral Suspension in people with Healthy Participants, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- GP681 tablet and GP681 Powder for Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Sep 2024to 16 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gender: Healthy male subjects.
- Age: 18 to 45 years (inclusive).
- Body Weight: Body mass index (BMI = weight (kg)/height2 (m2)) between 19.0 and 26.0 kg/m2 (inclusive), with body weight ≥ 50.0 kg.
- Taste Perception Ability: Successfully passed the taste perception ability test.
- Informed Consent: Fully understands the study's purpose, nature, requirements, methodology, and potential adverse reactions; voluntarily agrees to participate in the clinical trial and signs the informed consent form prior to any study procedures.
- Contraception: Subject (and their partner) has no plans to conceive or donate sperm from the time of first dosing until 3 months after the last dose and agrees to use effective contraception during this period.
Who cannot join
- Clinically significant abnormalities, as determined by the investigator, including history of neurological, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, musculoskeletal, or other disorders that could affect study results, or history of gastrointestinal disease within 3 months prior to screening.
- Inability to accurately express true taste perception.
- Dysfunction in taste or olfactory senses.
- Known hypersensitivity or allergy to the investigational product or any of its components (e.g., copovidone, crospovidone, lactose, microcrystalline cellulose, mannitol, maltitol, hydroxypropyl methylcellulose, colloidal silicon dioxide, sodium stearyl fumarate, sucralose, strawberry flavoring), or history of allergic diseases or a predisposition to allergies.
- Clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray (posteroanterior view), or QTcF >450 ms, as assessed by the investigator.
- Positive test results for hepatitis B surface antigen (HBsAg), HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
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- Smoking ≥10 cigarettes per day within 3 months prior to the first dose.
- Surgical procedure within 3 months before the first dose or planned surgery during the study period.
- Blood donation or significant blood loss ≥400 mL within 3 months before the first dose, or plans to donate blood within 3 months after the study.
- Participation in another clinical drug trial within 3 months before the first dose.
- Difficulty swallowing.
- Intolerance to skin puncture, fear of blood or needles, or poor venous access for blood sampling.
- Special dietary requirements or inability to adhere to the provided diet and study dietary restrictions.
- Positive urine drug screen, history of substance abuse within the past 5 years, or use of illicit drugs within 3 months before the first dose.
- Alcohol consumption exceeding 21 units per week (1 unit = 360 mL beer, 45 mL spirits with 40% alcohol, or 150 mL wine) within 6 months prior to screening, or a positive breath alcohol test.
- Use of any drugs known to inhibit or induce hepatic drug metabolism (e.g., inducers like barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors like SSRIs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedatives, verapamil, fluoroquinolones, antihistamines) within 30 days before the first dose.
- Use of any prescription drugs, over-the-counter medications, herbal remedies, or supplements within 2 weeks prior to the first dose.
- Vaccination within 2 weeks before the first dose, or planned vaccination during the study.
- Consumption of foods or beverages rich in caffeine, poppy seeds, and/or theobromine, theophylline, or grapefruit (e.g., coffee, strong tea, chocolate, caffeinated carbonated drinks, cola, grapefruit juice) within 48 hours before the first dose, or engaging in vigorous exercise within 48 hours before the first dose.
- Any other condition deemed unsuitable for study participation by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-site, Randomized, Single-dose, Two-Period, Crossover Study to Assess the Relative Bioavailability of GP681 Powder for Oral Suspension and Tablet Formulations in Healthy Chinese Male Subjects
The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.
- Conditions
- Healthy Participants
- Being tested
- GP681 tablet, GP681 Powder for Oral Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP681 tabletDrug
Also called Reference treatment
GP681 tablet, 20 mg, single oral dose in each Group.
GP681 Powder for Oral SuspensionDrug
Also called Test Treatment
GP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence T-R | Experimental | Not described Receives: Drug: GP681 tablet; Drug: GP681 Powder for Oral Suspension |
| Treatment sequence R-T | Experimental | Not described Receives: Drug: GP681 tablet; Drug: GP681 Powder for Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration[AUC(0-T)]
Measured: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)]
Measured: Up to 360 hours post-dose
Secondary outcomes (9)
Time of maximum observed concentration(Tmax)
Measured: Up to 360 hours post-dose
Apparent terminal half-life (T-HALF)
Measured: Up to 360 hours post-dose
Incidence of adverse events (AEs)
Measured: Up to approximately 1 month post-dose
Incidence of serious adverse events (SAEs)
Measured: Up to approximately 1 month post-dose
Incidence of participants with vital sign abnormalities
Measured: Up to approximately 1 month post-dose
Incidence of participants with physical examinations abnormalities
Measured: Up to approximately 1 month post-dose
Incidence of participants with electrocardiogram (ECG) abnormalities
Measured: Up to approximately 1 month post-dose
Incidence of participants with clinical laboratory abnormalities
Measured: Up to approximately 1 month post-dose
Palatability Evaluation
The palatability of GP681 Powder for Oral Suspension will be evaluated to characterize and quantify the sensory attributes of the product, such as basic tastes (including bitterness, astringency, sweetness) and texture (grittiness). Overall acceptability will also be assessed.
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start27 Sep 2024
- Primary completion16 Feb 2025
- Study completion16 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678542
- Sponsor's protocol ID
- 2024-GP681-S-BA/CRC-C2413
- Status last verified
- Mar 2025
- First submitted
- 30 Oct 2024
- Last updated
- 14 Mar 2025
- Results posted
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-site, Randomized, Single-dose, Two-Period, Crossover Study to Assess the Relative Bioavailability of GP681 Powder for Oral Suspension and Tablet Formulations in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT06678542
- Acronym / sponsor ID
- 2024-GP681-S-BA/CRC-C2413
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 16 Feb 2025 (actual)
- Study completion
- 16 Feb 2025 (actual)
- First posted
- 7 Nov 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 primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence T-R | Experimental | Drug: GP681 tablet, Drug: GP681 Powder for Oral Suspension |
| Treatment sequence R-T | Experimental | Drug: GP681 tablet, Drug: GP681 Powder for Oral Suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Gender: Healthy male subjects.
- Age: 18 to 45 years (inclusive).
- Body Weight: Body mass index (BMI = weight (kg)/height2 (m2)) between 19.0 and 26.0 kg/m2 (inclusive), with body weight ≥ 50.0 kg.
- Taste Perception Ability: Successfully passed the taste perception ability test.
- Informed Consent: Fully understands the study's purpose, nature, requirements, methodology, and potential adverse reactions; voluntarily agrees to participate in the clinical trial and signs the informed consent form prior to any study procedures.
Key exclusion criteria (20 listed)
- Clinically significant abnormalities, as determined by the investigator, including history of neurological, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, musculoskeletal, or other disorders that could affect study results, or history of gastrointestinal disease within 3 months prior to screening.
- Inability to accurately express true taste perception.
- Dysfunction in taste or olfactory senses.
- Known hypersensitivity or allergy to the investigational product or any of its components (e.g., copovidone, crospovidone, lactose, microcrystalline cellulose, mannitol, maltitol, hydroxypropyl methylcellulose, colloidal silicon dioxide, sodium stearyl fumarate, sucralose, strawberry flavoring), or history of allergic diseases or a predisposition to allergies.
- Clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray (posteroanterior view), or QTcF >450 ms, as assessed by the investigator.
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 |
|---|---|---|
| GP681 tabletAlso: Reference treatmentGP681 tablet, 20 mg, single oral dose in each Group. | Drug | Treatment sequence R-T, Treatment sequence T-R |
| GP681 Powder for Oral SuspensionAlso: Test TreatmentGP681 Powder for Oral Suspension, 20 mg, single oral dose in each Group. | Drug | Treatment sequence R-T, Treatment sequence T-R |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration[AUC(0-T)]
Time frame: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)]
Time frame: Up to 360 hours post-dose
9 secondary outcomes
Time of maximum observed concentration(Tmax)
Time frame: Up to 360 hours post-dose
Apparent terminal half-life (T-HALF)
Time frame: Up to 360 hours post-dose
Incidence of adverse events (AEs)
Time frame: Up to approximately 1 month post-dose
Incidence of serious adverse events (SAEs)
Time frame: Up to approximately 1 month post-dose
Incidence of participants with vital sign abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with physical examinations abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to approximately 1 month post-dose
Incidence of participants with clinical laboratory abnormalities
Time frame: Up to approximately 1 month post-dose
Palatability Evaluation
Time frame: Up to 24 hours post-dose
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 14 Mar 2025.
- 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.
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 GP681 tablet and GP681 Powder for Oral Suspension in people with Healthy Participants, run by Jiangxi Qingfeng 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 6 inclusion and 20 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 14 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to 360 hours post-dose). 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 14 Mar 2025.