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

Sponsor
Dong-A Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01851512
Collaborator
(none)
27
Enrollment
2
Arms
11
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: T-R (Test-Reference drug)
  • Drug: R-T (Reference-Test drug)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

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: Ovidrel liquid injection (Referecne drug)
  • Drug: DA-3803 (Test drug)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentration in serum of hCG examined by non-compartmental analysis [3 weeks]

      Examine the following: Maximum blood concentration Travel time of maximum blood concentration half time t(1/2) Clearance Volume of distribution

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong-A Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01851512
    Other Study ID Numbers:
    • DA3803_HCG_I
    First Posted:
    May 10, 2013
    Last Update Posted:
    May 16, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Infertility
    Chorionic Gonadotropin

    Study Results

    No Results Posted as of May 16, 2013