Clinical trial · Interventional
Bioequivalency Study of CM082 Tablet in Healthy Volunteers
Randomized,Open Label,Two-cycle,Crossover,Single Dose Bioequivalency Study of Two Preparations of CM082 Tablet in Healthy Chinese Volunteers Under Fasted State and After Meal
NCT04328506CI-TRIAL-00055259completedPhase 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 CM082 tablet 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 |
|---|---|---|---|
| Advanced Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM082 tablet (reference product) | Drug | — | UNRESOLVED |
| CM082 tablet (test product) | Drug | — | UNRESOLVED |
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 CM082 tablet (test product) under fasted state, after a wash period of 5 days, the subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state.
- interventionNames
- Drug: CM082 tablet (test product)
- Drug: CM082 tablet (reference product)
- type
- EXPERIMENTAL
- label
- R-T cohort under fasted state
- description
- Subjects will be administered with one single dose of CM082 tablet (reference product) under fasted state, after a wash period of 5 days,the subjects will be administered with one single dose of CM082 tablet (test product) under fasted state.
- interventionNames
- Drug: CM082 tablet (test product)
- Drug: CM082 tablet (reference product)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 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 * Intolerant of venipuncture, history of fainting needle and blood * Lactose intolerant * Drug abusing in 3 months * Donated ≥200 mL of blood within 3 months before screening * Pregnant or under lactation period (female subjects) * Received any prescription drug, over-the-counter drug, prescription drug and Chinese herbal drug in 2 weeks, with the exception of vitamins and acetaminophen * 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.