Induction of Ovulation, Infertility
Conditions
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.
Interventions
Sponsors
Dong-A Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed