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Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers

NCT06254235 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-02-12

No results posted yet for this study

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

Interventions

DRUG

The test octreotide microsphere

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

DRUG

The reference octreotide microsphere

A single intramuscular dose of the reference octreotide microsphere 30mg

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-16
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06254235 on ClinicalTrials.gov