drugset
drugset / Trial / NCT06864793

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

NCT06864793 ↗

Phase 1 Active not recruiting 48 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start
2025-04-06
Primary completion
2026-02-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gonal-f Protein / enzyme biologic 225 iu Subcutaneous

Indications

female infertility