Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

Bioequivalence Study of Octreotide Acetate Microsphere Injection in Human

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: The test octreotide microsphere; Drug: The reference octreotide microsphere

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Reference	Drug: The reference octreotide microsphere; A single intramuscular dose of the reference octreotide microsphere 30mg
Experimental: Test	Drug: The test octreotide microsphere; A single intramuscular dose of the test octreotide microsphere 30mg,

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Octreotide
• Other Study ID Numbers: QL-YXZ2-006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No