Clinical trial · Interventional
Effect of Rifampicin on the Pharmacokinetics of Apatinib
Effect of Rifampicin on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
NCT02836821CI-TRIAL-00026164completedPhase 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 primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with rifampicin. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with rifampicin.
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 |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib Mesylate Tablets | Drug | — | UNRESOLVED |
| Rifampicin Capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- subjects receiving a single 750 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then rifampicin capsules 600 mg/day orally for 10 days with a single 750 mg oral dose of apatinib mesylate tablets co-administered on day 8 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h
- interventionNames
- Drug: Apatinib Mesylate Tablets
- Drug: Rifampicin Capsules
Primary outcomes (1)
- measure
- Area under the plasma concentration versus time curve (AUC) of Apatinib
- timeFrame
- 0~72h after apatinib administration
Secondary outcomes (2)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * female of non-childbearing potential or male; * age 18-45 years; * body mass index 19-24 kg/m2 with total body weight; Exclusion Criteria: * clinically significant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs; * history of alcohol abuse; smoker; * electrocardiogram(ECG) abnormality; * blood pressure \>140/90 mmHg; * treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication; * Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.
References
Publications (0)
Data not yet available
No reference posted for this study.