Clinical trial · Interventional
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of Ensartinib Capsules in Healthy Chinese Volunteers Under Fasted State and After Meal
NCT03536481CI-TRIAL-00039707completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ensartinib capsules (reference product) | Drug | Ensartinib | ALIAS |
| ensartinib capsules (test product) | Drug | Ensartinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- T-R cohort under fasted state
- description
- Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state.
- interventionNames
- Drug: ensartinib capsules (test product)
- Drug: ensartinib capsules (reference product)
- type
- EXPERIMENTAL
- label
- R-T cohort under fasted state
- description
- Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state.
- interventionNames
- Drug: ensartinib capsules (test product)
- Drug: ensartinib capsules (reference product)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male body weight≥50.0kg or female body weight≥45.0kg; BMI between 19.0-26.0 kg/m2(inclusive) * Generally in good health, with no history of chronic disease or sever disease * No (clinical significant) abnormal findings in clinical laboratory tests and physical examinations * No plan for pregnancy in coming 6 months, and must practice effective contraception; No plan for sperm or egg donation * Written informed consent Exclusion Criteria: * History of food or drug allergies * Clinical significant disease or disorders * Received surgery in 3 months before screening, or have plan for surgery during the study * Participated in other clinical trials within 3 months before screening * Venipuncture intolerance * Drug abusing in 6 months * Donated ≥200 mL of blood within 30 days before screening * Pregnant or under lactation period (female subjects) * Received any prescription drug, over-the-counter drug, Chinese herbal drug or vitamins in 2 weeks * Received any vaccine in 4 weeks * Excessively smoking, alcohol or coffin-containing beverage drinking in 3 months * Other circumstances that is deemed not appropriate for the study
References
Publications (0)
Data not yet available
No reference posted for this study.