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ACTIVE NOT RECRUITING
NCT06864793
PHASE1

Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this Interventional study is to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers. It aims to evaluate the bioequivalence of recombinant human follicle stimulating hormone injection (QL1012D) and Gonal-F®, both given subcutaneously.

Official title: A Randomized, Double-blind, Two-Period, Crossover Study to Compare the Pharmacokinetics and Safety of Recombinant Human Follicle Stimulating Hormone Injection (QL1012D) and Gonal-F® in Healthy Female Volunteers

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-04-06

Completion Date

2026-04

Last Updated

2026-02-17

Healthy Volunteers

Yes

Interventions

DRUG

QL1012D

A single Subcutaneous injection, 225IU

DRUG

Gonal-F®

A single Subcutaneous injection, 225IU

Locations (1)

The First Hospital of Jilin University

Changchun, Jilin, China