Phase 1 Comparative PK/PD and safety study of MYL-1401H Vs G-Lasta
- Conditions
- Reduction in the duration of neutropenia and the incidence of Febrile neutropenia in patients treate
- Registration Number
- JPRN-jRCT2071210138
- Lead Sponsor
- Koichi Iwai
- Brief Summary
The study demonstrated bioequivalence between MYL-1401H and G-Lasta based on the primary PK and PD parameters. Additionally, both products had similar safety and tolerability profile after the single administration
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 171
A subject will be eligible at the screening visit (unless otherwise stated) if all of the Protocol apply
1 Willingness and ability to provide informed consent.
2 Japanese male and/or female
3 Age: 20-55 years, inclusive.
4 Weight: >45 kg.
In addition, follow the criteria of the clinical trial protocol
A subject will be not be eligible at the screening visit (unless otherwise stated) if any of the Protocol apply
1 Unable to follow protocol instructions in the opinion of the PI/SI.
2 Any past or concurrent medical conditions that potentially increase the subjects risks or affect the evaluation of any study results. Examples of these include medical history with evidence of clinically relevant pathology (e.g., sickle cell disorders,spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as acute respiratory distress syndrome (ARDS), interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis) and history of relevant drug and/or food allergies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK Endpoints,PD Endpoints
- Secondary Outcome Measures
Name Time Method PK Endpoints,PD Endpoints,Safety Endpoints