Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

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