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A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.

NCT03458650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2018-05-30

No results posted yet for this study

Summary

"This study is a single-center, randomized, double-blinded and placebo-controlled trial designed not only to assess pharmacokinetics, safety and tolerability of LXI-15028 but also to evaluate the pharmacokinetic characteristics of main metabolite M1 in vivo in 38 healthy adult Chinese subjects after receiving escalating single oral doses of 50 mg, 100 mg and 200 mg and multiple oral doses of 100 mg of LXI-15028.

Conditions

  • Healthy

Interventions

DRUG

LXI-15028 50mg

In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state,

DRUG

LXI-15028 100mg

100 mg LXI-15028 tablet or matching placebo 1 tablet at fasted state, In multiple-dose study, the subjects who administered 100mg single dose will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times.

DRUG

LXI-15028 200mg

single oral dose 2 100 mg LXI-15028 tablets or 2 matching placebo tablets at fasted state

DRUG

Placebo

matching placebo tablets

Sponsors & Collaborators

  • Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jing Zhang, Doctor · Chief technician

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2018-04-23
Completion
2018-05-08

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03458650 on ClinicalTrials.gov