Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

Qilu Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: The test octreotide microsphere

Drug: The reference octreotide microsphere

Study type

Interventional

Funder types

Industry

Identifiers

NCT06254235

QL-YXZ2-006

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts 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