Healthy Volunteers
Conditions
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.
Interventions
DRUGThe test octreotide microsphere
A single intramuscular dose of the test octreotide microsphere 30mg,
DRUGThe reference octreotide microsphere
A single intramuscular dose of the reference octreotide microsphere 30mg
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-28d | Day 0-28 | The area under the concentration-time curve from dosing to Day 28 |
| AUC28-56d | Day 28-56 | The area under the concentration-time curve from Day 28 to Day 56 |
| AUC0-t | Day 0-82 | The area under the concentration-time curve from dosing to the last quantifiable time-point |
| AUC0-∞ | Day 0-82 | The area under the concentration-time curve extrapolated to infinity |
| Cmax | Day 0-82 | The maximum drug concentration |
Countries
China
Outcome results
None listed