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The Pharmacokinetic and Bioavailability of GenSci094 Before and After a Change in Manufacturing Site

NCT06095206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-12-03

No results posted yet for this study

Summary

The bioavailability study is intended to evaluate the pharmacokinetic (PK) characteristics and the bioavailability of the two formulations in humans before and after the change of production site, in order to assess the possible impact of the site change on the pharmacokinetic characteristics of the drug and to clarify whether the two formulations are comparable before and after the change.

Conditions

Interventions

DRUG

GenSci094

On the morning of day 1 pre-meal, a single SC injection of 150 μg GenSci094 was administered in the abdominal wall.

Sponsors & Collaborators

  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaolan Yong, bachelor · chengdu xinhua hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2023-11-07
Completion
2023-11-13

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 NCT06095206 on ClinicalTrials.gov