Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: The reference octreotide microsphere; Drug: The test octreotide microsphere

• Registration Number: NCT06254235
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-16
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Study First Submitted: 2024-01-22
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-03
• Last Update Submitted: 2024-02-03
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	The reference octreotide microsphere	-
Test	The test octreotide microsphere	-

Primary Outcome Measures

Name	Time	Method
Cmax	Day 0-82	The maximum drug concentration
AUC28-56d	Day 28-56	The area under the concentration-time curve from Day 28 to Day 56
AUC0-∞	Day 0-82	The area under the concentration-time curve extrapolated to infinity
AUC0-t	Day 0-82	The area under the concentration-time curve from dosing to the last quantifiable time-point
AUC0-28d	Day 0-28	The area under the concentration-time curve from dosing to Day 28

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China