Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GZR4 injection A, GZR4 injection B.
- Who it may be relevant to
- Registry conditions: T2D. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Open-label, Single-dose Study to Evaluate the Bioequivalence of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants
Overview
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
Interventions
- Drug GZR4 injection A
GZR4 s.c., single-dose - Drug GZR4 injection B
GZR4 s.c., single-dose
Primary outcome measures
- Cmax [Time frame: Day1-Day29]
- AUC₀-t [Time frame: Day1-Day29]
- AUC₀-∞ [Time frame: Day1-Day29]
Secondary outcome measures (3)
- Tmax [Time frame: Day1-Day29]
- t1/2 [Time frame: Day1-Day29]
- AUC_%Extrap [Time frame: Day1-Day29]
Eligibility criteria
Inclusion criteria
- 1\. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.
2\. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening.
4\. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.
Exclusion criteria
- 1\. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.
2\. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator.
3\. Have special dietary requirements and are unable to comply with the standardized diet.
4\. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling.
5\. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Gan & Lee Pharmaceuticals Shandong Co., Ltd., — Linyi
Identifiers
NCT: NCT07670897 · GZR4-T2D-106