Drug-drug InteractionPhase 1NCT05108051
Study to Investigate the Potential Drug-Drug Interaction Between ZSP1273 and Oseltamivir
A Phase 1 study testing ZSP1273 and Oseltamivir in people with Drug-drug Interaction, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug-drug Interaction
- What is being tested?
- ZSP1273 and Oseltamivir
- 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
- 19 Nov 2020to 17 Mar 2021
- 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
- Males and female subjects between 18-45 years (Both inclusive);
- Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18~26 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
- Subjects (including partners) are willing to voluntarily use effective contraception from screening to 3 months after the last study drug administration.
Who cannot join
- Known history of allergic constitution (multiple drugs especially with ZSP1273 or oseltamivir and its preparation of the main ingredient allergy, food allergy);
- Subjects who donated blood or bleeding profusely(> 450 mL)in the 3 months preceding study screening;
- History or presence of any disease or condition known to increase the risk of bleeding, eg.hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc;
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening;
- Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of drug metabolic enzymes ，is intended to be taken in combination 28 days prior to screening or during the study period；
- Participated in another clinical research study or received any investigational products within 3 months prior to dosing;
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- Presence of clinically significant abnormalities in ECG , QTcB>450ms in males,or QTcB>470ms in females;
- Any of the following diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular diseases) that are clinically significant in clinical laboratory examination or other clinical findings within 6 months prior to screening;
- Breast-feeding women or those with positive pregnancy test results;
- Subjects who should not be included in the study in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510000
About this study
Official title: A Phase 1, Open-Label, Three-Period, Single-center Study to Assess the Pharmacokinetic Interactions Between ZSP1273 and Oseltamivir in Healthy Subjects
To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.
- Conditions
- Drug-drug Interaction
- Being tested
- ZSP1273, Oseltamivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273Drug
ZSP1273 tablets 600mg administered orally once daily
OseltamivirDrug
Oseltamivir 75mg administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| sequence 1 | Experimental | Period 1: study of ZSP1273's pharmacokinetics at steady state； Period 2: study of Oseltamivir's pharmacokineticsat at steady state； Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state. Receives: Drug: ZSP1273; Drug: Oseltamivir |
| sequence 2 | Experimental | Period 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state. Receives: Drug: ZSP1273; Drug: Oseltamivir |
| sequence 3 | Experimental | Period 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state. Receives: Drug: ZSP1273; Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetics
Tmax
Measured: pre-dose and up to 72hours post-dose
Plasma pharmacokinetics
t1/2
Measured: pre-dose and up to 72hours post-dose
Plasma pharmacokinetics
Cmax
Measured: pre-dose and up to 72hours post-dose
Plasma pharmacokinetics
AUC0-∞
Measured: pre-dose and up to 72hours post-dose
Plasma pharmacokinetics
CL/F
Measured: pre-dose and up to 72hours post-dose
Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
Measured: up to 37days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start19 Nov 2020
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug-drug InteractionStudies 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
- 36 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
- NCT05108051
- Sponsor's protocol ID
- ZSP1273-20-05
- Status last verified
- Oct 2021
- First submitted
- 29 Sep 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pang Y, Li H, Chen X, Cao Y, Jiang H, Huang J, Liu Y. A phase I, single-center, randomized, open-label, three-period crossover study to evaluate the drug-drug interaction between ZSP1273 and oseltamivir in healthy Chinese subjects. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0172924. doi: 10.1128/aac.01729-24. Epub 2025 Feb 24.
PubMed 39992105
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Three-Period, Single-center Study to Assess the Pharmacokinetic Interactions Between ZSP1273 and Oseltamivir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05108051
- Acronym / sponsor ID
- ZSP1273-20-05
- Conditions
- Drug-drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 4 Nov 2021 (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.
To evaluate the drug-drug interaction between ZSP1273 and oseltamivir, the pharmacokinetic characteristics and safety of ZSP1273 and oseltamivir in healthy subjects, so as to provide a basis for the design of administration regimen in subsequent clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sequence 1 | Experimental | Drug: ZSP1273, Drug: OseltamivirPeriod 1: study of ZSP1273's pharmacokinetics at steady state； Period 2: study of Oseltamivir's pharmacokineticsat at steady state； Period 3: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state. |
| sequence 2 | Experimental | Drug: ZSP1273, Drug: OseltamivirPeriod 1: study of Oseltamivir's pharmacokineticsat at steady state; Period 2: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 3: study of ZSP1273's pharmacokinetics at steady state. |
| sequence 3 | Experimental | Drug: ZSP1273, Drug: OseltamivirPeriod 1: study of ZSP1273's pharmacokinetics under Oseltamivir at steady state; Period 2: study of ZSP1273's pharmacokinetics at steady state; Period 3: study of Oseltamivir's pharmacokineticsat at steady state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males and female subjects between 18-45 years (Both inclusive);
- Body weight is no less than 50kg in males and no less than 45kg in females.Body mass index (BMI) 18~26 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
- Subjects (including partners) are willing to voluntarily use effective contraception from screening to 3 months after the last study drug administration.
Key exclusion criteria (10 listed)
- Known history of allergic constitution (multiple drugs especially with ZSP1273 or oseltamivir and its preparation of the main ingredient allergy, food allergy);
- Subjects who donated blood or bleeding profusely(> 450 mL)in the 3 months preceding study screening;
- History or presence of any disease or condition known to increase the risk of bleeding, eg.hemorrhoids, acute gastritis or gastric and duodenal ulcer, etc;
- Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal within 14 days prior to screening;
- Concomitant therapy with any drugs with known hepatic enzyme-inducing or inhibiting agents that may change the activity of drug metabolic enzymes ，is intended to be taken in combination 28 days prior to screening or during the study 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 |
|---|---|---|
| ZSP1273ZSP1273 tablets 600mg administered orally once daily | Drug | sequence 1, sequence 2, sequence 3 |
| OseltamivirOseltamivir 75mg administered orally twice daily | Drug | sequence 1, sequence 2, sequence 3 |
Primary outcome
Plasma pharmacokinetics
Time frame: pre-dose and up to 72hours post-dose
Tmax
Plasma pharmacokinetics
Time frame: pre-dose and up to 72hours post-dose
t1/2
Plasma pharmacokinetics
Time frame: pre-dose and up to 72hours post-dose
Cmax
Plasma pharmacokinetics
Time frame: pre-dose and up to 72hours post-dose
AUC0-∞
Plasma pharmacokinetics
Time frame: pre-dose and up to 72hours post-dose
CL/F
Number of treatment-emergent adverse events (TEAEs) and Serious Adverse Events(SAE)
Time frame: up to 37days
TEAEs will be summarized displaying the number of TEAEs along with the number and percentage of participants with at least one TEAE according to: Number of AEs, Severity and relation to study drug.
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 4 Nov 2021.
- Derived from this study: PubMed 39992105Pang Y, Li H, Chen X, Cao Y, Jiang H, Huang J, Liu Y. A phase I, single-center, randomized, open-label, three-period crossover study to evaluate the drug-drug interaction between ZSP1273 and oseltamivir in healthy Chinese subjects. Antimicrob Agents Chemother. 2025 Apr 2;69(4):e0172924. doi: 10.1128/aac.01729-24. Epub 2025 Feb 24.
- 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 ZSP1273 and Oseltamivir in people with Drug-drug Interaction, 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 10 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 4 Nov 2021. 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?
Plasma pharmacokinetics (time frame: pre-dose and up to 72hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05108051, which also lists 1 linked publication.
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 Nov 2021.