Overview

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

Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dong-A Pharmaceutical Co., Ltd.
Treatments:
Chorionic Gonadotropin
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