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The Assessment of Single-Dose Safety,Tolerability, Pharmacokinetics and Pharmacodynamic of Globalagliatin Hydrochloride

NCT03171623 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-01-31

No results posted yet for this study

Summary

This is a phase 1 randomized,double-blind,placebo-controlled study with single oral dose of globalagliatin hydrochloride (SY-004) administered to chinese healthy subjects to evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of globalagliatin hydrochloride (SY-004).

Conditions

  • Hyperglycaemia (Diabetic)
  • Healthy Volunteers

Interventions

DRUG

globalagliatin hydrochloride

orally administration, single dose

DRUG

placebo

orally administration, single dose

Sponsors & Collaborators

  • Yabao Pharmaceutical Group

    lead INDUSTRY

Principal Investigators

  • Lei Yang · Yabao pharmaceutical Group Co.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2017-09-25
Completion
2018-01-09

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 NCT03171623 on ClinicalTrials.gov