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

Dong-A Pharmaceutical Co., Ltd.27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infertility Induction of Ovulation

Interventions

T-R (Test-Reference drug)DRUG

R-T (Reference-Test drug)DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 3 weeks

Data from ClinicalTrials.gov

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