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

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.

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Key information

Conditions

Infertility Genital Diseases Induction of Ovulation Urogenital Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-R (Test-Reference drug)

Drug

Other names: Drug: DA-3803 (Test drug), Drug: Ovidrel liquid injection (Referecne drug)

R-T (Reference-Test drug)

Drug

Other names: Drug: Ovidrel liquid injection (Referecne drug), Drug: DA-3803 (Test drug)

Primary outcomes

Concentration in serum of hCG examined by non-compartmental analysis

Time frame: 3 weeks
Examine the following:
- Maximum blood concentration
- Travel time of maximum blood concentration
- half time t(1/2)
- Clearance
- Volume of distribution

Sponsors and collaborators

Lead sponsor

Dong-A Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Single-Blind, Randomized, Comparative, Phase I Study to Evaluate the Tolerability, Safety, and Pharmacokinetic Characteristics of Human Chorionic Gonadotropin Between Two Recombinant hCG Products, DA-3803 Injection and Ovidrel Liquid Injection, in Healthy Subjects

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2011
First posted: May 10, 2013
Registry last updated: May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed