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The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers

NCT03173599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-06-02

No results posted yet for this study

Summary

A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.

Conditions

Interventions

DRUG

PNA 40mg

The beginning dose is 40mg.

DRUG

PNA 80mg

The single dose is 80mg.

DRUG

PNA 160mg

The single dose is 160mg.

DRUG

PNA 240mg

The single dose is 240mg.

DRUG

PNA 360mg

The single dose is 360mg.

DRUG

PNA 480mg

The single dose is 480mg.

DRUG

PNA Placebo

The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.

Sponsors & Collaborators

  • Guangzhou Yipinhong Pharmaceutical CO.,LTD

    lead INDUSTRY

Principal Investigators

  • Yimin Mao · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03173599 on ClinicalTrials.gov