Effect of Itraconazole on the Pharmacokinetics of Apatinib

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Apatinib Mesylate Tablets
* Drug: Itraconazole Capsules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>subjects receiving a single 250 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then Itraconazole capsules 100 mg/day orally for 6 days with a single 250 mg oral dose of apatinib mesylate tablets co-administered on day 4 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h | Drug: Apatinib Mesylate Tablets<br>* apatinib was administered in the morning after an overnight fast of at least 10 h<br>* Other names: apatinib;Drug: Itraconazole Capsules<br>* rifampicin was administered in the morning 0.5 hours after breakfast<br>* Other names: itraconazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration versus time curve (AUC) of Apatinib |  | 0 72h after apatinib administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |