A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
Primary Purpose
Infertility, Induction of Ovulation
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
T-R (Test-Reference drug)
R-T (Reference-Test drug)
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
T-R (Test-Reference drug)
R-T (Reference-Test drug)
Arm Description
DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
Outcomes
Primary Outcome Measures
Concentration in serum of hCG examined by non-compartmental analysis
Examine the following:
Maximum blood concentration
Travel time of maximum blood concentration
half time t(1/2)
Clearance
Volume of distribution
Secondary Outcome Measures
Full Information
NCT ID
NCT01851512
First Posted
May 8, 2013
Last Updated
May 15, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01851512
Brief Title
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
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 Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Induction of Ovulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T-R (Test-Reference drug)
Arm Type
Experimental
Arm Description
DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
Arm Title
R-T (Reference-Test drug)
Arm Type
Experimental
Arm Description
Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
Intervention Type
Drug
Intervention Name(s)
T-R (Test-Reference drug)
Other Intervention Name(s)
Drug: DA-3803 (Test drug), Drug: Ovidrel liquid injection (Referecne drug)
Intervention Type
Drug
Intervention Name(s)
R-T (Reference-Test drug)
Other Intervention Name(s)
Drug: Ovidrel liquid injection (Referecne drug), Drug: DA-3803 (Test drug)
Primary Outcome Measure Information:
Title
Concentration in serum of hCG examined by non-compartmental analysis
Description
Examine the following:
Maximum blood concentration
Travel time of maximum blood concentration
half time t(1/2)
Clearance
Volume of distribution
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji-Young Park, M.D., Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kyoung-Ah Kim, Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Un Jip Kim, M.D., Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soo Kyung Kim, M.D., Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hyun Tae Park, M.D., Ph.D.
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
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