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
Overview
- Phase
- Phase 1
- Intervention
- T-R (Test-Reference drug)
- Conditions
- Infertility
- Sponsor
- Dong-A Pharmaceutical Co., Ltd.
- Enrollment
- 27
- Primary Endpoint
- Concentration in serum of hCG examined by non-compartmental analysis
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
Arms & Interventions
T-R (Test-Reference drug)
DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
Intervention: T-R (Test-Reference drug)
R-T (Reference-Test drug)
Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
Intervention: R-T (Reference-Test drug)
Outcomes
Primary Outcomes
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