Clinical trial · Interventional
A Study to Investigate the Food Effect on the Pharmacokinetics of CM082 Tablet in Chinese Healthy Volunteers
A Pharmacokinetic Study in Chinese Healthy Male and Female Volunteers to Investigate the Effect of Food on the Pharmacokinetics of CM082 Tablet.
NCT04126668CI-TRIAL-00045217completedPhase 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 Effect of Food on the Pharmacokinetics of CM082 tablet.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM082 with fed or fasting | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Period 1: fasted control → Period 2: fed control
- description
- Period 1: administration of CM082 200 mg at 7:30am, without the breakfast;Period 2: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast
- interventionNames
- Drug: CM082 with fed or fasting
- type
- EXPERIMENTAL
- label
- Period 1: fed control → Period 2: fasted control
- description
- Period 1: administration of CM082 200 mg at 7:30am, 30 minutes after the breakfast;Period 2: administration of CM082 200 mg at 7:30am, without the breakfast
- interventionNames
- Drug: CM082 with fed or fasting
Primary outcomes (4)
- measure
- Peak plasma concentration (Cmax) of CM082
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * age: 18 - 45 years; * sex: male and female; * body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border); * Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests; * Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available; * Written informed consent; Exclusion Criteria: * Received any investigational drugs within 14 days before the screening test; * Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study; * Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period; * History of drug or food allergies; * Abnormal blood pressure or pulse,Abnormal laboratory tests; * Participated in other clinical trials within 3 months before screening; * Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive; * Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody; * Clinically apparent disease/infection within 1 month before screening; * The researchers determined that there were other conditions that were not suitable for the trial;
References
Publications (0)
Data not yet available
No reference posted for this study.