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Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

NCT03988413 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2020-04-30

No results posted yet for this study

Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study.

The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Conditions

  • Diabetic Neuropathy Peripheral

Interventions

DRUG

25mg

SYHA1402 25mg or Placebo 25mg

DRUG

50mg

SYHA1402 50mg or Placebo 50mg

DRUG

100mg

SYHA1402 100mg or Placebo 100mg

DRUG

200mg

SYHA1402 200mg or Placebo 200mg

DRUG

400mg

SYHA1402 400mg or Placebo 400mg

DRUG

800mg

SYHA1402 800mg or Placebo 800mg

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2020-01-14
Completion
2020-01-14

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 NCT03988413 on ClinicalTrials.gov