Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01851512
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

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
Infertility Induction of Ovulation Drug: T-R (Test-Reference drug) Drug: R-T (Reference-Test drug) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851512


Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01851512     History of Changes
Other Study ID Numbers: DA3803_HCG_I
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs