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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Infertility; Induction of Ovulation

Treatments: Drug: R-T (Reference-Test drug); Drug: T-R (Test-Reference drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01851512

DA3803_HCG_I

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 2 patient groups

T-R (Test-Reference drug)

Experimental group

Description:

DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period

Treatment:

Drug: T-R (Test-Reference drug)

R-T (Reference-Test drug)

Experimental group

Description:

Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period

Treatment:

Drug: R-T (Reference-Test drug)