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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04428086
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib in arm1 — DRUG
    Apatinib will be administered at a dose of 250 mg once daily from Day 4 to Day 9.
  • Rosuvastatin — DRUG
    Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 7.
  • Apatinib in arm2 — DRUG
    Apatinib will be administered at a dose of 250 mg once daily from Day 3 to Day 7.
  • Metformin — DRUG
    Metformin will be administered as a single oral 500 mg on Day 1 and Day 6.

Study Details

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.

Key Dates

Start date
Jul 27, 2020
Status verified
Jul 2022
Primary completion
Aug 22, 2021
Completion
Aug 22, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Assess PK effects of Apatinib on Rosuvastatin
    Participant will be administered a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 and Day 7 and Apatinib at a dose of 250 mg once daily from Day 4 until Day 9.
  • Experimental: Assess PK effects of Apatinib on Metformin
    Participant will be administered a single oral dose of metformin 500 milligram (mg) on Day 1 and Day 6 and Apatinib at a dose of 250 mg once daily from Day 3 until Day 7.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Up to Day 10 ]

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