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