Clinical trial NCT06254235: Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
Official title: Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Researchers will compare pharmacokinetic characteristics of the two formulations to see if they are bioequivalent.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: AUC0-28d
timeFrame: Day 0-28
measure: AUC28-56d
timeFrame: Day 28-56
measure: AUC0-t
timeFrame: Day 0-82
measure: AUC0-∞
timeFrame: Day 0-82
measure: Cmax
timeFrame: Day 0-82
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: