Healthy VolunteersPhase 1NCT06254235
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
A Phase 1 study testing The test octreotide microsphere and The reference octreotide microsphere in people with Healthy Volunteers, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers. Participants will receive single-dose of either test or reference octreotide microsphere formulations. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- The test octreotide microsphere and The reference octreotide microsphere
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2021to 1 Dec 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
- BMI 19-28 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
- In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
- Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
- Fully understood and voluntarily signed the informed consent form
- With high compliance
Who cannot join
- With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
- Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
- With gastrointestinal disease
- Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
- With alcohol consumption > 2 units/d within 6 months before screening
- With cigarette consumption > 5/d within 3 months before screening
Show all 20Show fewer
- Donated or lost blood > 400 mL within 3 months before screening
- Hospitalized or received surgery within 3 months before screening
- Received study drug of other clinical trial within 3 months before screening
- Received prescription drug within 14d before dosing
- Received over-the-counter drug or herb within 48h before dosing
- Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine within 72h before dosing
- Consumed alcohol within 48h before dosing or positive for breath alcohol test
- Cannot consume standard meal
- Intolerable to venipuncture
- Cannot receive intramuscular injection in the glute
- With vitamin B12 deficiency
- Had acute minor disease (common cold, diarrhea, etc.) from screening to dosing
- For pregnancy-capable female, breastfeeding or positive for pregnancy test at screening, or had unprotected sexual contact within 2 weeks before dosing
- Other reason judged by investigators
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
About this study
Official title: Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
- Conditions
- Healthy Volunteers
- Being tested
- The test octreotide microsphere, The reference octreotide microsphere
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The test octreotide microsphereDrug
A single intramuscular dose of the test octreotide microsphere 30mg,
The reference octreotide microsphereDrug
A single intramuscular dose of the reference octreotide microsphere 30mg
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Not described Receives: Drug: The test octreotide microsphere |
| Reference | Active comparator | Not described Receives: Drug: The reference octreotide microsphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-28d
The area under the concentration-time curve from dosing to Day 28
Measured: Day 0-28
AUC28-56d
The area under the concentration-time curve from Day 28 to Day 56
Measured: Day 28-56
AUC0-t
The area under the concentration-time curve from dosing to the last quantifiable time-point
Measured: Day 0-82
AUC0-∞
The area under the concentration-time curve extrapolated to infinity
Measured: Day 0-82
Cmax
The maximum drug concentration
Measured: Day 0-82
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start16 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 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 Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254235
- Sponsor's protocol ID
- QL-YXZ2-006
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang C, Li X, Gu X, Hu H, Lv Z, Sun Y, Li Y, Hao C, Liu Y, Fu Y, Yang Q, Cao Y. Pharmacokinetic and Bioequivalence Evaluation of Prolonged-Release Octreotide Acetate Microspheres in Healthy Human Subjects. Clin Pharmacol Drug Dev. 2025 Jul;14(7):505-510. doi: 10.1002/cpdd.1521. Epub 2025 May 12.
PubMed 40353390
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
- ClinicalTrials.gov ID
- NCT06254235
- Acronym / sponsor ID
- QL-YXZ2-006
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 12 Feb 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 goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
Participants will receive single-dose of either test or reference octreotide microsphere formulations.
Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: The test octreotide microsphere |
| Reference | Active comparator | Drug: The reference octreotide microsphere |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 19-28 kg/m^2, and with weight ≥ 50 kg for male, or ≥ 45 kg for female
- In good physical condition (without any history of disease or clinically relevantly abnormal vital sign or examination
- Agreed to use adequate contraception and did not plan for pregnancy from screening period throughout 6 months after study completion
- Fully understood and voluntarily signed the informed consent form
- With high compliance
Key exclusion criteria (20 listed)
- With allergic disease or allergic to any component of the study drugs or more than two kinds of other drug, food, or beverage
- Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
- With gastrointestinal disease
- Had drug addiction within 5 years or used narcotics within 6 months before screening or positive in drug of abuse test
- With alcohol consumption > 2 units/d within 6 months before 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 |
|---|---|---|
| The test octreotide microsphereA single intramuscular dose of the test octreotide microsphere 30mg, | Drug | Test |
| The reference octreotide microsphereA single intramuscular dose of the reference octreotide microsphere 30mg | Drug | Reference |
Primary outcome
AUC0-28d
Time frame: Day 0-28
The area under the concentration-time curve from dosing to Day 28
AUC28-56d
Time frame: Day 28-56
The area under the concentration-time curve from Day 28 to Day 56
AUC0-t
Time frame: Day 0-82
The area under the concentration-time curve from dosing to the last quantifiable time-point
AUC0-∞
Time frame: Day 0-82
The area under the concentration-time curve extrapolated to infinity
Cmax
Time frame: Day 0-82
The maximum drug concentration
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 12 Feb 2024.
- Derived from this study: PubMed 40353390Wang C, Li X, Gu X, Hu H, Lv Z, Sun Y, Li Y, Hao C, Liu Y, Fu Y, Yang Q, Cao Y. Pharmacokinetic and Bioequivalence Evaluation of Prolonged-Release Octreotide Acetate Microspheres in Healthy Human Subjects. Clin Pharmacol Drug Dev. 2025 Jul;14(7):505-510. doi: 10.1002/cpdd.1521. Epub 2025 May 12.
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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 The test octreotide microsphere and The reference octreotide microsphere in people with Healthy Volunteers, run by Qilu 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 5 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 12 Feb 2024. 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?
AUC0-28d (time frame: Day 0-28). The study lists 5 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 NCT06254235, 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 12 Feb 2024.