Clinical trials: Gefitinib
Bioequivalence Study
Bioequivalence Study of Gefitinib Tablets Under Fasting Conditions
The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan…
- Trial name
- NCT03050164
- Testing
- Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Non-Small Cell Lung Cancer, Brain Metastases
Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal Growth Factor Receptor;BM-brain Metastases)
1. Compare the effect and safety of gefitinib alone with gefitinib plus concomitant WBRT(whole-brain radiotherapy ) in treatment of NSCLC patients harboring an EGFR mutation with multiple BM. 2.
- Conditions
- Non-Small Cell Lung Cancer, Brain Metastases, EGFR Gene Mutation
- Trial name
- EGFR (NCT02338011)
- Testing
- Gefitinib, WBRT
- Where
- China
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Shanghai Chest Hospital
Healthy
Bioequivalence Study of Gefitinib Tablets Under Fed Conditions
The study design is an Open-Label，Randomized, Single-Dose, 2-way Crossover Bioequivalence Study. During each session, the subjects will be administered a single dose of 250mg Gefitinib Tablet (one Gefitinib Tablet 250mg of Hunan…
- Trial name
- NCT03050177
- Testing
- Gefitinib Tablet 250mg of Hunan Kelun, Iressa® Tablet 250mg of AZN
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.