Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

NCT ID: NCT06254235

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2021-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

Group Type: EXPERIMENTAL

The test octreotide microsphere

Intervention Type: DRUG

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

Reference

Group Type: ACTIVE_COMPARATOR

The reference octreotide microsphere

Intervention Type: DRUG

A single intramuscular dose of the reference octreotide microsphere 30mg

Interventions

The test octreotide microsphere

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

Intervention Type: DRUG

The reference octreotide microsphere

A single intramuscular dose of the reference octreotide microsphere 30mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Countries

China

Other Identifiers

QL-YXZ2-006

Identifier Type: -

Identifier Source: org_study_id