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A Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets in Healthy Chinese Male Volunteers

NCT03860948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-05-16

No results posted yet for this study

Summary

This is a single-center, randomized, open lebal, single-dose, three-period, crossover clinical study in healthy Chinese male subjects to assess the pharmacokinetics and bioequivalence/bioavailability of two formulation savolitinib tablets.

Conditions

  • Bioequivalence

Interventions

DRUG

Savolitinib Test Preparation

Test preparation (T): dry granulation savolitinib tablets.

DRUG

Savolitinib Reference Preparation

Reference preparation (R): wet granulation savolitinib tablets.

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Jingying Jia · Shanghai Xuhui District Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2019-05-02
Completion
2019-05-14

Countries

  • China

Study Locations

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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 NCT03860948 on ClinicalTrials.gov