Status:
COMPLETED
A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Conditions:
Infertility
Induction of Ovulation
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
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 prod...
Eligibility Criteria
Inclusion
- No medical history relating to the alimentary system, liver system, heart system, haematological disease
- Ideal body weight +/- 20%
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01851512
Start Date
May 1 2010
End Date
April 1 2011
Last Update
May 16 2013
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