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A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese

NCT02786069 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-05-30

No results posted yet for this study

Summary

The main objective is to evaluate the effect of single dose Propionyl-L-Carnitine Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for market authorization registration.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Propionyl L-carnitine Hydrochloride

500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Principal Investigators

  • Heng-yan Qu · National Clinical Trial Institution of Affiliated Hospital of Military Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-11-30
Completion
2016-01-31

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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 NCT02786069 on ClinicalTrials.gov