Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

NCT06254235 | Completed Phase 1

• 1 other identifier: QL-YXZ2-006
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Test

EXPERIMENTAL

Drug: The test octreotide microsphere

Reference

ACTIVE COMPARATOR

Drug: The reference octreotide microsphere

Interventions

The test octreotide microsphere DRUG

A single intramuscular dose of the test octreotide microsphere 30mg,

Test

The reference octreotide microsphere DRUG

A single intramuscular dose of the reference octreotide microsphere 30mg

Reference

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 12, 2024
• Study Start: June 16, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

CN (1)