Effect of Rifampicin on the Pharmacokinetics of Apatinib
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ClinicalTrials.gov Identifier: NCT02836821 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : February 27, 2017
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms | Drug: Apatinib Mesylate Tablets Drug: Rifampicin Capsules | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Rifampicin on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers |
Study Start Date : | May 2016 |
Actual Primary Completion Date : | February 2017 |
Actual Study Completion Date : | February 2017 |

Arm | Intervention/treatment |
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Experimental: Apatinib
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
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Drug: Apatinib Mesylate Tablets
apatinib was administered in the morning after an overnight fast of at least 10 h
Other Name: apatinib Drug: Rifampicin Capsules rifampicin was administered in the morning 2 hours after breakfast
Other Name: rifampin |
- Area under the plasma concentration versus time curve (AUC) of Apatinib [ Time Frame: 0~72h after apatinib administration ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From first administration to the seventh day after last administration ]
- Peak Plasma Concentration (Cmax) of Apatinib [ Time Frame: 0~72h after apatinib administration ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836821
China, Shanghai | |
Shanghai Xuhui Central Hospital | |
Shanghai, Shanghai, China, 200030 |
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02836821 |
Other Study ID Numbers: |
HR-APTN-DDI-02 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | February 27, 2017 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Rifampin Apatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |
Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |