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

NCT01851512 | Completed Phase 1

• 1 other identifier: DA3803_HCG_I
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility; Induction of Ovulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

T-R (Test-Reference drug)

EXPERIMENTAL

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

Drug: T-R (Test-Reference drug)

R-T (Reference-Test drug)

EXPERIMENTAL

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

Drug: R-T (Reference-Test drug)

Interventions

T-R (Test-Reference drug) DRUG

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

T-R (Test-Reference drug)

R-T (Reference-Test drug) DRUG

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

R-T (Reference-Test drug)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No medical history relating to the alimentary system, liver system, heart system, haematological disease
• Ideal body weight +/- 20%

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Infertility

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Ji-Young Park, M.D., Ph.D.

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

• Kyoung-Ah Kim, Ph.D.

  Korea University Anam Hospital

  STUDY DIRECTOR

• Un Jip Kim, M.D., Ph.D.

  Korea University Anam Hospital

  STUDY DIRECTOR

• Soo Kyung Kim, M.D., Ph.D.

  Korea University Anam Hospital

  STUDY DIRECTOR

• Hyun Tae Park, M.D., Ph.D.

  Korea University Anam Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: April 1, 2011
• Last Updated: May 16, 2013

Record last verified: 2013-05