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

Phase 1

Completed

• Conditions: Infertility; Induction of Ovulation
• Interventions: Drug: T-R (Test-Reference drug); Drug: R-T (Reference-Test drug)

• Registration Number: NCT01851512
• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2010-08
• Study Completion: 2011-04
• Status Verified: 2013-05
• Study First Submitted: 2013-05-08
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-10
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
T-R (Test-Reference drug)	T-R (Test-Reference drug)	DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
R-T (Reference-Test drug)	R-T (Reference-Test drug)	Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period

Primary Outcome Measures

Name	Time	Method
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