drugset / Trial / NCT01851512

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

NCT01851512

Phase 1 Completed 27 enrolled Dong-A Pharmaceutical Co., Ltd.
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2010-05
Primary completion
2010-08
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject DA-3803 Protein / enzyme biologic
Subject Ovidrel Protein / enzyme biologic

Indications