NCT04428086

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

Open-Label, Fixed-Sequence Study in Solid Tumor Subjects to Investigate the Pharmacokinetic Interaction Between Apatinib and Transporter Substrates Rosuvastatin and Metformin.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-07-27
• Primary completion: 2021-08-22
• Completion: 2021-08-22
• First posted: 2020-06-11
• Last updated: 2022-07-26

Locations

1 site across 1 country: China