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InfertilityPhase 1NCT01851512

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

A Phase 1 study testing T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Infertility and Induction of Ovulation, run by Dong-A Pharmaceutical Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Infertility, Induction of Ovulation
What is being tested?
T-R (Test-Reference drug) and R-T (Reference-Test drug)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
No sites listed yet
Study dates
May 2010to Apr 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • acute disease within 28 days
  • medical history that might affect the absorption, distribution, secretion, metabolism of drugs
  • metrectomy surgery
  • desexualization
  • tubal ligation
  • menopause
Show all 10Show fewer
  • pregnancy
  • not able to use contraception
  • drink alcohol more than 14 units/week
  • smoker who smokes 10 or more cigarettes

About this study

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

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.

Being tested
T-R (Test-Reference drug), R-T (Reference-Test drug)
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-R (Test-Reference drug)Drug

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

  • R-T (Reference-Test drug)Drug

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

Study groups in NCT01851512
Study groupRoleWhat they receive
T-R (Test-Reference drug)ExperimentalDA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period
Receives: Drug: T-R (Test-Reference drug)
R-T (Reference-Test drug)ExperimentalOvidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period
Receives: Drug: R-T (Reference-Test drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2013 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2010
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01851512
Sponsor's protocol ID
DA3803_HCG_I
Status last verified
May 2013
First submitted
8 May 2013
Last updated
16 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T-R (Test-Reference drug) and R-T (Reference-Test drug) in people with Infertility and Induction of Ovulation, run by Dong-A Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration in serum of hCG examined by non-compartmental analysis (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01851512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.

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