Completed

A Randomized, Open-label, Crossover Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets Produced by Two Different Processes in Healthy Chinese Male Volunteers

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What is being tested

Savolitinib Test Preparation

+ Savolitinib Reference Preparation

Drug
Who is being recruted

From 18 to 40 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2019
See protocol details

Summary

Principal SponsorHutchison Medipharma Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 16, 2019

Actual date on which the first participant was enrolled.

Thirty six Chinese male subjects who met the inclusion criteria but not met the exclusion criteria, will be hospitalized in Phase I Ward one day before first dosing and randomized into three groups, 12 subjects each, at a ratio of 1:1:1. The subjects in the different group will follow the fixed dosing regimen with 600 mg savolitinib tablets (200 mg/tablet x 3 tablets) after the standard meal on day 1 in cycle 1, 2 and 3 respectively: TRR, RTR or RRT, where "T" indicates dry granulation savolitinib tablet and "R" indicates wet granulation savolitinib tablet. PK blood samples, 2 mL each time, will be collected at the following time points in each dosing cycle: within 0.5 hours before dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hours after dosing(16 time-points).

Official TitleA Randomized, Open-label, Crossover Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets Produced by Two Different Processes in Healthy Chinese Male Volunteers
NCT03860948
Principal SponsorHutchison Medipharma Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Subjects must agree to comply with the protocol and Informed consent must be obtained in writing for all subjects;
Healthy male subjects aged 18 to 45 years inclusive at the time of screening;
Weight ≥ 50 kg, body mass index (BMI) of 19-26 kg/m2;
No clinically significant abnormalities or findings in medical history, vital signs, physical examination, 12-lead ECG and laboratory values;
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12 exclusion criteria prevent from participating
History or symptoms of a clinically significant illness in metabolic/ endocrine, liver, kidney, blood, lung, immune system, cardiovascular, gastrointestinal, genitourinary, neurological, or psychiatric systerm in the 3 months before the study, as determined by the investigator;
History of gastrointestinal surgery, kidney surgery and cholecystectomy, which may potentially affect the absorption or excretion of drugs, as determined by the investigator ;
History of a severe allergy (for example, certain drug allergy) and acute allergic rhinitis or food allergy within 2 weeks prior to the screening stage;
Serum albumin < 35 g/L;
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The subjects in this arm will receive Test preparation (T). T is dry granulation savolitinib tablets.

Group II

Experimental
The subjects in this arm will receive Reference preparation(R). R is wet granulation savolitinib tablets.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shanghai Xuhui District Central Hospital

Shanghai, ChinaOpen Shanghai Xuhui District Central Hospital in Google Maps
CompletedOne Study Center
A Randomized, Open-label, Crossover Pharmacokinetic and Bioequivalence Study of Savolitinib Tablets Produced by Two Different Processes in Healthy Chinese Male Volunteers | PatLynk