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A Bioequivalence Study of Sunitinib Malate Capsules.

NCT05800106 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-10

No results posted yet for this study

Summary

A randomized, open, two-period, two-sequence crossover trial design used to assess the pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.

Conditions

Interventions

DRUG

Sunitinib malate capsules generic product

Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).

DRUG

Sunitinib malate capsules reference product

Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2019-01-06
Completion
2019-01-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05800106 on ClinicalTrials.gov