NCT01851512

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

Single-Blind, Randomized, Comparative, Phase I Study to Evaluate the Tolerability, Safety, and Pharmacokinetic Characteristics of Human Chorionic Gonadotropin Between Two Recombinant hCG Products, DA-3803 Injection and Ovidrel Liquid Injection, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Dong-A Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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

• Infertility
• Induction of Ovulation

Interventions

Type	Name	Description
DRUG	T-R (Test-Reference drug)
DRUG	R-T (Reference-Test drug)

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-08-01
• Completion: 2011-04-01
• First posted: 2013-05-10
• Last updated: 2013-05-16