Trials / Not Yet Recruiting
Not Yet RecruitingNCT06840691
A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations
A Randomized, Open-lable, Single-dose, 3-sequence, 3-period Crossover Bioequivalence Study of Two Different PEG-rhGH （2mg/mL）Preparations in Chinese Healthy Adults
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Detailed description
The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-rhGH with new preparation (T) | A single subcutaneous injection of PEG-rhGH with new preparation |
| DRUG | PEG-rhGH with present preparation (T) | A single subcutaneous injection of PEG-rhGH with present preparation |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2025-05-01
- Completion
- 2025-09-01
- First posted
- 2025-02-21
- Last updated
- 2025-02-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06840691. Inclusion in this directory is not an endorsement.