HealthyPhase 1NCT06226506
Comparative Pharmacokinetic Study of Aprepitant Injection in Humans
A Phase 1 study testing Test (T) Aprepitant injection and Reference (R) Aprepitant injection in people with Healthy, run by The Affiliated Hospital of Qingdao University.
Trial summary
This is a single-center, open, randomized, single-dose, two-cycle, two-sequence, crossover pharmacokinetic study in healthy adult subjects. The trial is planned to enroll 24 healthy subjects. Subjects will be randomized to one of two groups (Group A: T-R, Group B: R-T) according to the randomization table. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Test (T) Aprepitant injection and Reference (R) Aprepitant injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2024to 25 Jan 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Voluntarily sign an informed consent form before the trial and fully understand the content, process and possible adverse effects of the trial； 2. Ability to complete research in accordance with the requirements of the pilot program； 3. Subjects (including male subjects) who have been using effective contraception for 14 days prior to the first dose and who are willing to voluntarily use effective contraception from the time of signing the information until 6 months after the last dose without pregnancy, sperm or egg donation program； 4. Male and female subjects aged 18-45 years (both 18 and 45 years)； 5. Body mass index (BMI) within the range of 19.0~26.0kg/m2 (including threshold values) .
- -
Who cannot join
- Have a history of serious medical problems of the heart, liver, kidneys, gastrointestinal tract, nervous system, endocrine system, respiratory system, or mental abnormality, which in the opinion of the researcher are not suitable for the participant；
- Abnormalities of clinical significance as determined by the clinician, including physical examination, vital signs, electrocardiogram, or clinical laboratory testing；
- People with a history of specific allergies (asthma, etc.) or current allergic diseases (hives, eczema, etc.), or allergies (e.g., allergies to two or more medications, foods such as milk, or pollen), or allergies to any of soy, alcohol, or eggs, or known allergies to the components of this medication or to similar substances；
- Women who are pregnant or breastfeeding, or who have a positive pregnancy test, or who are using long-acting contraceptives or contraceptive implants；
- Positive for any one or more of the following: Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antibody, or Syphilis Antibody；
- History of substance abuse within five years, or drug use within 3 months prior to screening, or a positive urine drug screen；
Show all 18Show fewer
- Persons who have consumed an average of more than 14 units of alcohol (1 unit = 360milliliter of beer or 45milliliter of 40% alcohol by volume spirits or 150milliliter of wine) per week in the 3 months prior to screening, or who have been unable to stop alcohol intake from 24h prior to dosing until completion of blood sampling in that cycle, or who have had a positive breathalyzer test for alcohol；
- Those who smoked an average of more than 5 cigarettes per day in the 3 months prior to screening or who refused to stop using tobacco products during the stay；
- History of surgical procedure within 3 months prior to screening, or planned surgery during the study period；
- Blood donation or massive blood loss (>400milliliter, except physiologic blood loss in women) within 3 months prior to administration, or platelet donation of ≥2 therapeutic doses within 1 month；
- Participation in a clinical trial of any drug that was administered within the 3 months prior to administration；
- Those who have used any prescription medication within 14 days prior to dosing；
- Those who have used any over-the-counter medications, herbs, or supplements within 7 days prior to dosing；
- Pimozide or any other drug that inhibits or induces hepatic metabolism (e.g., inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; depressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamine) used within the last 30 days prior to administration. (including verapamil, fluoroquinolones, antihistamines)；
- Those who have taken special diets (e.g., grapefruit and grapefruit-containing products), or had strenuous exercise, or other factors affecting the absorption, distribution, metabolism, or excretion of the drug within 48 hours prior to the administration of the drug；
- Anyone who has consumed any xanthine-rich food (e.g. coffee, tea, chocolate, cocoa, milk tea, etc.) in the 48h prior to administration；
- Those who have difficulty collecting blood, or who cannot tolerate venipuncture, or who have a history of blood or needle-sickness；
- Subjects judged by other investigators to be unsuitable for participation. -
Trial locations and contacts
No sites are listed yet.
About this study
This is a single-center, open, randomized, single-dose, two-cycle, two-sequence, crossover pharmacokinetic study in healthy adult subjects.
The trial is planned to enroll 24 healthy subjects. Subjects will be randomized to one of two groups (Group A: T-R, Group B: R-T) according to the randomization table. The washout period (dosing interval) between doses will be at least 7 days. For example, for a washout period of 7 days, all subjects will receive the appropriate drug according to the randomized schedule on Day 1 of Cycle 1 and Day 8 of Cycle 2 of the trial.
- Conditions
- Healthy
- Being tested
- Test (T) Aprepitant injection, Reference (R) Aprepitant injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test (T) Aprepitant injectionDrug
Specification: Aprepitant injection 4.4ml∶32mg. Produced and supplied by Qilu Pharmaceutical (Hainan) Co.
Reference (R) Aprepitant injectionDrug
Specification: Aprepitant injection 4.4ml∶32mg. Produced by Heron Therapeutics, Inc and supplied by Qilu Pharmaceutical (Hainan) Co.
| Study group | Role | What they receive |
|---|---|---|
| Test (T)-Reference (R) | Experimental | In this trial, 24 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours. Receives: Drug: Test (T) Aprepitant injection; Drug: Reference (R) Aprepitant injection |
| Reference (R)-Test (T) | Experimental | In this trial, 24 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours. Receives: Drug: Test (T) Aprepitant injection; Drug: Reference (R) Aprepitant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 72 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: 72 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: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start23 Jan 2024 (estimated)
- Primary completion25 Jan 2024 (estimated)
- Study completion25 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cao Yu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226506
- Sponsor's protocol ID
- QLG2174-101
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Jan 2024
- 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic Study of Aprepitant Injection in Humans
- ClinicalTrials.gov ID
- NCT06226506
- Acronym / sponsor ID
- QLG2174-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (estimated)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 25 Jan 2025 (estimated)
- First posted
- 26 Jan 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.
This is a single-center, open, randomized, single-dose, two-cycle, two-sequence, crossover pharmacokinetic study in healthy adult subjects.
The trial is planned to enroll 24 healthy subjects. Subjects will be randomized to one of two groups (Group A: T-R, Group B: R-T) according to the randomization table. The washout period (dosing interval) between doses will be at least 7 days. For example, for a washout period of 7 days, all subjects will receive the appropriate drug according to the randomized schedule on Day 1 of Cycle 1 and Day 8 of Cycle 2 of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test (T)-Reference (R) | Experimental | Drug: Test (T) Aprepitant injection, Drug: Reference (R) Aprepitant injectionIn this trial, 24 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group A: Test (T)-Reference (R), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours. |
| Reference (R)-Test (T) | Experimental | Drug: Test (T) Aprepitant injection, Drug: Reference (R) Aprepitant injectionIn this trial, 24 healthy subjects are planned to be enrolled in fasting. According to the randomization table, subjects will be randomly assigned to the Group B: Reference (R)-Test (T), The washout period (dosing interval) between doses will be at least 7 days. After fasting for at least 10 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Voluntarily sign an informed consent form before the trial and fully understand the content, process and possible adverse effects of the trial； 2. Ability to complete research in accordance with the requirements of the pilot program； 3. Subjects (including male subjects) who have been using effective contraception for 14 days prior to the first dose and who are willing to voluntarily use effective contraception from the time of signing the information until 6 months after the last dose without pregnancy, sperm or egg donation program； 4. Male and female subjects aged 18-45 years (both 18 and 45 years)； 5. Body mass index (BMI) within the range of 19.0~26.0kg/m2 (including threshold values) .
- -
Key exclusion criteria (18 listed)
- Have a history of serious medical problems of the heart, liver, kidneys, gastrointestinal tract, nervous system, endocrine system, respiratory system, or mental abnormality, which in the opinion of the researcher are not suitable for the participant；
- Abnormalities of clinical significance as determined by the clinician, including physical examination, vital signs, electrocardiogram, or clinical laboratory testing；
- People with a history of specific allergies (asthma, etc.) or current allergic diseases (hives, eczema, etc.), or allergies (e.g., allergies to two or more medications, foods such as milk, or pollen), or allergies to any of soy, alcohol, or eggs, or known allergies to the components of this medication or to similar substances；
- Women who are pregnant or breastfeeding, or who have a positive pregnancy test, or who are using long-acting contraceptives or contraceptive implants；
- Positive for any one or more of the following: Hepatitis B Surface Antigen, Hepatitis C Antibody, HIV Antibody, or Syphilis Antibody；
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 |
|---|---|---|
| Test (T) Aprepitant injectionSpecification: Aprepitant injection 4.4ml∶32mg. Produced and supplied by Qilu Pharmaceutical (Hainan) Co. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
| Reference (R) Aprepitant injectionSpecification: Aprepitant injection 4.4ml∶32mg. Produced by Heron Therapeutics, Inc and supplied by Qilu Pharmaceutical (Hainan) Co. | Drug | Reference (R)-Test (T), Test (T)-Reference (R) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 72 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 72 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: 72 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 26 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test (T) Aprepitant injection and Reference (R) Aprepitant injection in people with Healthy, run by The Affiliated Hospital of Qingdao University.
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 2 inclusion and 18 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak Plasma Concentration (Cmax) (time frame: 72 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 26 Jan 2024.