Clinical trial · Interventional
A Food Effect Study of SPH5030 Tablets.
A Single-center, Randomized, Open, Single-dose, Two-cycle, Two-sequence Crossover Food Effect Study of SPH5030 Tablets in Healthy Chinese Adult Subjects.
NCT06372223CI-TRIAL-00076151completedPhase 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 purpose of this study is to evaluate the food effect of SPH5030 tablets in healthy Chinese adult subjects.
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 Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPH5030 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- interventionNames
- Drug: SPH5030
- type
- EXPERIMENTAL
- label
- Group B
- interventionNames
- Drug: SPH5030
Primary outcomes (3)
- measure
- Peak Plasma Concentration (Cmax)
- timeFrame
- Approximately 2 months
- description
- PK（Pharmacokinetics）
- measure
- Peak time（Tmax）
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully informed subjects who voluntarily sign the ICF； 2. Females who are not pregnant, non-lactating. Subjects who complied with the contraceptive requirements of the protocol. Exclusion Criteria: 1. Subjects with any medical history assessed by the investigator that unsuitable for participation in a clinical study; 2. Subjects with abnormal test results during the screening period； 3. Subjects who have difficulty in venous blood collection; 4. Subjects who cannot accept uniform diet or have difficulty swallowing; 5. Other situations that meet the exclusion criteria.
References
Publications (0)
Data not yet available
No reference posted for this study.