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

Infertility Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851512
• Other study ID #: DA3803_HCG_I
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2013
• Last updated: May 15, 2013
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induction of Ovulation
• Infertility

Intervention

Drug:
• T-R (Test-Reference drug)

• R-T (Reference-Test drug)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration in serum of hCG examined by non-compartmental analysis	Examine the following: Maximum blood concentration; Travel time of maximum blood concentration; half time t(1/2); Clearance; Volume of distribution	3 weeks	Yes