MedTrace Logo

A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803

NCT01851512 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2013-05-16

No results posted yet for this study

Summary

This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.

Conditions

Interventions

DRUG

T-R (Test-Reference drug)

DRUG

R-T (Reference-Test drug)

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ji-Young Park, M.D., Ph.D. · Korea University Anam Hospital

  • Kyoung-Ah Kim, Ph.D. · Korea University Anam Hospital

  • Un Jip Kim, M.D., Ph.D. · Korea University Anam Hospital

  • Soo Kyung Kim, M.D., Ph.D. · Korea University Anam Hospital

  • Hyun Tae Park, M.D., Ph.D. · Korea University Anam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2011-04-30

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 NCT01851512 on ClinicalTrials.gov