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The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects

NCT05336071 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-08

No results posted yet for this study

Summary

The study is a single-centre, randomized, open, 2-period, 2-sequence crossover design clinical trial. It is planned to enroll 24 healthy male subjects. Subjects will receive INS068 injection on Day1 and Day8.

Conditions

Interventions

DRUG

INS068 injection

Group A subjects were injected formulation T and formulation R of INS068 injection at Day1 and Day8.

DRUG

INS068 injection

Group B subjects were injected formulation R and formulation T of INS068 injection at Day1 and Day8.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2022-05-26
Completion
2022-06-02

Countries

  • China

Study Locations

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Entities

Diseases

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 NCT05336071 on ClinicalTrials.gov