Clinical trial · Interventional
Food-Effect and Metabolism Study in Healthy Subjects
A Phase I, Open-label, 2-sequence, Cross-over, Pharmacokinetic (PK) Study to Evaluate the Effect of the Food and to Identify the Metabolism of Fluzoparib in Healthy Subjects
NCT03062982CI-TRIAL-00026149completedPhase 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)
This study evaluates the food-effect of one-dose Fluzoparib in healthy subjects. The participants receive Fluzoparib 120mg in fed state in Period 1 followed by administration of Fluzoparib 120mg in fasted state in Period 2.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Administration of 120mg in fed state in Dosing Period 1 followed by administration of 120mg in fasted state in Dosing Period 2
- interventionNames
- Drug: Fluzoparib
- type
- EXPERIMENTAL
- label
- Group B
- description
- Administration of 120mg in fasted state in Dosing Period 1 followed by administration of 120mg in fed state in Dosing Period 2
- interventionNames
- Drug: Fluzoparib
Primary outcomes (4)
- measure
- Pharmacokinetics - Cmax
- timeFrame
- pre-dose and then 0.25、0.5、1、1.5、2、3、4、6、8、10、12、24、36、48、72、96h
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Able and willing to give written informed consent. * Must be willing to comply with the requirements of the study. * Willing to use a medically acceptable method (as defined by the Investigator) of birth control in the 6 months. * Male or female aged 18-50 years. * Weight more than 45kg, BMI within 18 and 28 kg/m2. * No clinically significant abnormalities in physical examination and lab tests. Exclusion Criteria: * Pregnant or breast-feeding women. * No history of alcohol or drug abuse within the past year. * Participation in any clinical trial of an experimental drug or device in the previous 3 months. * Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.