Therapeutic EquivalencyPhase 1NCT05225974
A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects
A Phase 1 study testing Liraglutide injection and Liraglutide injection(Victoza®) in people with Therapeutic Equivalency, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Equivalency
- What is being tested?
- Liraglutide injection and Liraglutide injection(Victoza®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2021to 19 Aug 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male vulunteers aged 18 and above.
- The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
- 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
- Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
- Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
- Participation in another clinical trial within 3 months.
- Smoking more than 5 cigarettes per day during the 3 months prior to screening.
- Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
- Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
Read the detailed description
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
- Conditions
- Therapeutic Equivalency
- Being tested
- Liraglutide injection, Liraglutide injection(Victoza®)
- Keywords
- Liraglutide;Pharmacokinetic;bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide injectionDrug
At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
Liraglutide injection(Victoza®)Drug
At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide injection | Experimental | Not described Receives: Drug: Liraglutide injection |
| Liraglutide injection(Victoza®) | Active comparator | Not described Receives: Drug: Liraglutide injection(Victoza®) |
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: 40 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Measured: 40 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Measured: 40 days
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Collection of adverse events
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start16 Jul 2021
- Primary completion30 Jul 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic EquivalencyStudies 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
- 32 participants (actual)
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
- NCT05225974
- Sponsor's protocol ID
- NBT-1698-P1
- Status last verified
- Jan 2022
- First submitted
- 28 Jan 2022
- Last updated
- 7 Feb 2022
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study
- ClinicalTrials.gov ID
- NCT05225974
- Acronym / sponsor ID
- NBT-1698-P1
- Conditions
- Therapeutic Equivalency
- Keywords
- Liraglutide;Pharmacokinetic;bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 7 Feb 2022 (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 study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
Detailed description
The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide injection | Experimental | Drug: Liraglutide injection |
| Liraglutide injection(Victoza®) | Active comparator | Drug: Liraglutide injection(Victoza®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male vulunteers aged 18 and above.
- The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
- 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 (6 listed)
- Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
- Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
- Participation in another clinical trial within 3 months.
- Smoking more than 5 cigarettes per day during the 3 months prior to screening.
- Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
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 |
|---|---|---|
| Liraglutide injectionAt a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection | Drug | Liraglutide injection |
| Liraglutide injection(Victoza®)At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection | Drug | Liraglutide injection(Victoza®) |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 40 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 40 days
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 40 days
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 7 Feb 2022.
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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 Liraglutide injection and Liraglutide injection(Victoza®) in people with Therapeutic Equivalency, 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 3 inclusion and 6 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 7 Feb 2022. 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?
Peak Plasma Concentration (Cmax) (time frame: 40 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 7 Feb 2022.