HealthyPhase 1NCT03200496
Pharmacokinetics and Safety/Tolerability Profiles of DA-5206 Versus Talion® Under Fasting and Fed States in Healthy Male Subjects
A Phase 1 study testing DA-5206(Fasting), DA-5206(Fed) and TALION® in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DA-5206(Fasting), DA-5206(Fed) and TALION®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2017to 29 Jun 2017
- 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 19 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer 19 years to 45 years
- Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
- The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate
Who cannot join
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with acute disease within 28 days before the first dose of Investigational product
- Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects
- Conditions
- Healthy
- Being tested
- DA-5206(Fasting), DA-5206(Fed), TALION®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-5206(Fasting)Drug
Test drug l : DA-5206(Fasting)
DA-5206(Fed)Drug
Test drug ll : DA-5206(Fed)
TALION®Drug
Reference drug : Talion®
| Study group | Role | What they receive |
|---|---|---|
| TALION® | Experimental | Not described Receives: Drug: TALION® |
| DA-5206(Fasting) | Experimental | Not described Receives: Drug: DA-5206(Fasting) |
| DA-5206(Fed) | Experimental | Not described Receives: Drug: DA-5206(Fed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
PK Parameter
Measured: 0~24hr
Peak Plasma Concentration (Cmax)
PK Parameter
Measured: 0~24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start29 May 2017
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200496
- Sponsor's protocol ID
- DA5206_BE_Ⅰ
- Status last verified
- Jul 2017
- First submitted
- 26 Jun 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Pharmacokinetics and Safety/Tolerability Profiles Between DA-5206 and Talion® Under Fasting and Fed States in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03200496
- Acronym / sponsor ID
- DA5206_BE_Ⅰ
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2017 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is Open-label, Randomized, 3-sequence study to compare of pharmacokinetics and safety/tolerability profiles betweens DA-5206, a SR formulation of bepotastine besilate and Talion®, a IR formulation of bepotastine besilate under fasting and fed states in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TALION® | Experimental | Drug: TALION® |
| DA-5206(Fasting) | Experimental | Drug: DA-5206(Fasting) |
| DA-5206(Fed) | Experimental | Drug: DA-5206(Fed) |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteer 19 years to 45 years
- Body mass index in the range of 18 to 29 kg/m2 and body weight greater than 50 kg
- The subjects personally signed and dated informed consent document after informed of all pertinent aspects of the study, fully understanding and determided spontaneously to participate
Key exclusion criteria (4 listed)
- Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, endocrine, urologic, immunologic, dermal, neurologic, or psychological disease or history of such disease
- Subject with acute disease within 28 days before the first dose of Investigational product
- Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- Subjects who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DA-5206(Fasting)Test drug l : DA-5206(Fasting) | Drug | DA-5206(Fasting) |
| DA-5206(Fed)Test drug ll : DA-5206(Fed) | Drug | DA-5206(Fed) |
| TALION®Reference drug : Talion® | Drug | TALION® |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: 0~24hr
PK Parameter
Peak Plasma Concentration (Cmax)
Time frame: 0~24hr
PK Parameter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DA-5206(Fasting), DA-5206(Fed) and TALION® in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
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 3 inclusion and 4 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Area under the plasma concentration versus time curve (AUC) (time frame: 0~24hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017.