Trials / Active Not Recruiting
Active Not RecruitingNCT06864793
Study on the Pharmacokinetics and Safety of QL1012D and Gonal-F® in Healthy Female Volunteers
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | QL1012D | A single Subcutaneous injection, 225IU |
| DRUG | Gonal-F® | A single Subcutaneous injection, 225IU |
Timeline
- Start date
- 2025-04-06
- Primary completion
- 2026-02-04
- Completion
- 2026-04-01
- First posted
- 2025-03-07
- Last updated
- 2026-02-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06864793. Inclusion in this directory is not an endorsement.