Effect of Rifampicin on the Pharmacokinetics of Apatinib
Phase 1
Completed
- Conditions
- Neoplasms
- Interventions
- Registration Number
- NCT02836821
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apatinib Rifampicin Capsules 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 Apatinib Apatinib Mesylate Tablets 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
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) of Apatinib 0~72h after apatinib administration
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 From first administration to the seventh day after last administration Peak Plasma Concentration (Cmax) of Apatinib 0~72h after apatinib administration
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital
🇨🇳Shanghai, Shanghai, China