Healthy VolunteersPhase 1NCT05168176
Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects in the Fasting and Fed State
A Phase 1 study testing Dotilavir sodium tablet and Dotilavir sodium tablet(Tivicay@) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dotilavir sodium tablet and Dotilavir sodium tablet(Tivicay@)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Jan 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
- The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
- The subjects have no family planning within 3 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily
Who cannot join
- Subjects with allergic constitution.
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
- Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
- Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Yu Cao, Doctor, +86-18661809090, caoyu1767@126.com
About this study
Official title: Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study
The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.
- Conditions
- Healthy Volunteers
- Being tested
- Dotilavir sodium tablet, Dotilavir sodium tablet(Tivicay@)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dotilavir sodium tabletDrug
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
Dotilavir sodium tablet(Tivicay@)Drug
The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg.
| Study group | Role | What they receive |
|---|---|---|
| Dotilavir sodium tablet | Experimental | Not described Receives: Drug: Dotilavir sodium tablet |
| Dotilavir sodium tablet(Tivicay@) | Active comparator | Not described Receives: Drug: Dotilavir sodium tablet(Tivicay@) |
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: 31 days
Area under the plasma concentration versus time curve (AUC0-t)
Evaluation of Area under the plasma concentration versus time curve (AUC0-t）
Measured: 31days
Area under the plasma concentration versus time curve (AUC0-∞)
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
Measured: 31days
Secondary outcomes (2)
Incidence of Treatment-Emergent Adverse Events
Collection of adverse events
Measured: 31days
Incidence of abnormal blood pressure
Monitor both systolic and diastolic blood pressure
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Dec 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168176
- Sponsor's protocol ID
- QL-YK1-045-001
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 23 Dec 2021
- 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 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence of Dotilavir Sodium Tablets in Healthy Subjects: A Single-center, Open, Randomized, Single-dose, Crossover Study
- ClinicalTrials.gov ID
- NCT05168176
- Acronym / sponsor ID
- QL-YK1-045-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 23 Dec 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.
The primary purpose of this study is to evaluate the bioequivalence of two dotilavir sodium tablets in the fasting and fed state. The secondary purpose of this study is to observe the safety of the test and reference preparations. An open-label, randomized, single-dose, crossover study in healthy Chinese volunteers was performed. A single oral dose of 50 mg of two dotilavir sodium tablets was administered to 64 healthy volunteers, with 36 in the fasted group and 28 consuming a high-fat diet. The evaluated pharmacokinetic parameters, including maximum concentration (Cmax), the area under the concentration-time curve (AUC0-t and AUC0-∞) were assessed for bioequivalence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotilavir sodium tablet | Experimental | Drug: Dotilavir sodium tablet |
| Dotilavir sodium tablet(Tivicay@) | Active comparator | Drug: Dotilavir sodium tablet(Tivicay@) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects ≥18 years of age, with appropriate sex ratio
- The body mass index is in the range of 19.0-27.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg
- The subjects have no family planning within 3 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily
Key exclusion criteria (5 listed)
- Subjects with allergic constitution.
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
- Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening;
- Hepatitis (including hepatitis B and C), positive screening results for AIDS or syphilis;
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 |
|---|---|---|
| Dotilavir sodium tabletThe subjects randomly received single oral administration of Dotilavir sodium tablet 50mg. | Drug | Dotilavir sodium tablet |
| Dotilavir sodium tablet(Tivicay@)The subjects randomly received single oral administration of Dotilavir sodium tablet 50mg. | Drug | Dotilavir sodium tablet(Tivicay@) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 31 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 31days
Evaluation of Area under the plasma concentration versus time curve (AUC0-t）
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 31days
Evaluation of Area under the plasma concentration versus time curve (AUC0-∞)
2 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 31days
Incidence of abnormal blood pressure
Time frame: 31 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
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 Dotilavir sodium tablet and Dotilavir sodium tablet(Tivicay@) in people with Healthy Volunteers, run by The Affiliated Hospital of Qingdao University 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 5 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 23 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yu Cao, doctor (86 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: 31 days). 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 23 Dec 2021.