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A Pharmacokinetic Interaction Study Between Apatinib and Rosuvastatin or Metformin in Solid Tumor Subjects.

NCT04428086 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-07-26

No results posted yet for this study

Summary

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib on Rosuvastatin or Metformin.

The secondary objective of the study was to assess the safety of Apatinib alone or Rosuvastatin/Metformin alone or concomitant medication.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

Apatinib in arm1

Apatinib will be administered at a dose of 250 mg once daily from Day 4 to Day 9.

DRUG

Rosuvastatin

Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 7.

DRUG

Apatinib in arm2

Apatinib will be administered at a dose of 250 mg once daily from Day 3 to Day 7.

DRUG

Metformin

Metformin will be administered as a single oral 500 mg on Day 1 and Day 6.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2021-08-22
Completion
2021-08-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428086 on ClinicalTrials.gov