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

Primary Purpose

Infertility, Induction of Ovulation

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

T-R (Test-Reference drug)

R-T (Reference-Test drug)

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

T-R (Test-Reference drug)

R-T (Reference-Test drug)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01851512

First Posted

May 8, 2013

Last Updated

May 15, 2013

Sponsor

Dong-A Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01851512

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Induction of Ovulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T-R (Test-Reference drug)

Arm Type

Experimental

Arm Description

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

Arm Title

R-T (Reference-Test drug)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

T-R (Test-Reference drug)

Other Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

R-T (Reference-Test drug)

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Concentration in serum of hCG examined by non-compartmental analysis

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ji-Young Park, M.D., Ph.D.

Organizational Affiliation