Neoplasms
Conditions
Brief summary
he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.
Interventions
apatinib was administered in the morning after an overnight fast of at least 10 h
rifampicin was administered in the morning 0.5 hours after breakfast
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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 signiWcant 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of Apatinib | 0~72h after apatinib administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed