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

May 15, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No medical history relating to the alimentary system, liver system, heart system, haematological disease
  • Ideal body weight +/- 20%

Exclusion Criteria:

  • acute disease within 28 days
  • medical history that might affect the absorption, distribution, secretion, metabolism of drugs
  • metrectomy surgery
  • desexualization
  • tubal ligation
  • menopause
  • pregnancy
  • not able to use contraception
  • drink alcohol more than 14 units/week
  • smoker who smokes 10 or more cigarettes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T-R (Test-Reference drug)
DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
Drug: T-R (Test-Reference drug)
Other Names:
  • Drug: DA-3803 (Test drug)
  • Drug: Ovidrel liquid injection (Referecne drug)
Experimental: R-T (Reference-Test drug)
Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
Drug: R-T (Reference-Test drug)
Other Names:
  • Drug: DA-3803 (Test drug)
  • Drug: Ovidrel liquid injection (Referecne drug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration in serum of hCG examined by non-compartmental analysis
Time Frame: 3 weeks

Examine the following:

  • Maximum blood concentration
  • Travel time of maximum blood concentration
  • half time t(1/2)
  • Clearance
  • Volume of distribution
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Ji-Young Park, M.D., Ph.D., Korea University Anam Hospital
  • Study Director: Kyoung-Ah Kim, Ph.D., Korea University Anam Hospital
  • Study Director: Un Jip Kim, M.D., Ph.D., Korea University Anam Hospital
  • Study Director: Soo Kyung Kim, M.D., Ph.D., Korea University Anam Hospital
  • Study Director: Hyun Tae Park, M.D., Ph.D., Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

May 16, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3803_HCG_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on T-R (Test-Reference drug)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe