HealthyNCT03932435
Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"
A study testing Fisrt period TWLO_C, Fisrt period TWLO and Washout period in people with Healthy, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fisrt period TWLO_C, Fisrt period TWLO and Washout period
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2019to 28 May 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A person who aged 19 or older at the time of screening
- No congenital or chronic diseases or pathological symptoms on screening
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- BMI of 18 to 30 (BMI calculation: kg/m2)
- No history of gastrointestinal resection that may affect the absorption of drugs
- No medical history of mental illness within five years prior to screening
Show all 9Show fewer
- A person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature
- A person who is willing and able to follow all scheduled hospitalization and outpatient visits, medications, clinical laboratory examination and the terms of compliance
- Female patients who were confirmed to be not pregnant at medical examination
Who cannot join
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to screening
- A person who uses drugs that can affect the study within 10 days before screening
- A person who is considered unsuitable to participate in the study by the investigator
- A person who has participated in other clinical trials within three months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before screening
- A person who is hypersensitive to venipuncture
Show all 13Show fewer
- A person with a history of regular alcohol intake within six months prior to screening:
- Women: More than 14 cups/week
- Men: More than 21 glasses/week (1 shot: 50 ml of soju, 30 ml of spirits, 250 ml of beer)
- Hypersensitive to any of the IP components
- Blood AST (GOT) or ALT (GPT) levels exceed the upper reference range limit by 2 times or γ-GTP levels exceed the upper reference range limit by 1.5 times
- Lactating women
- A person who does not agree to exclude the possibility of pregnancy using the contraception from the date of the first administration of the IP until the 7th day after the last administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers
An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers
Read the detailed description
- Study design: An open-Label, randomized, 2-sequence, 2-period, fasted condition, single-dose, per oral, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Bepotastine Besilate 10 mg) with 150 mL of water at around 8 a.m. on the day of the test at room temperature. The test subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time.
- Wash out period: 7 days
- Blood collection time: Before the administration, 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12 hr after the administration (total 13 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Bepotastine in plasma
- Conditions
- Healthy
- Being tested
- Fisrt period TWLO_C, Fisrt period TWLO, Washout period, Second period TWLO_C, Second period TWLO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisrt period TWLO_CDrug
Also called "Dong-a Bepotastine Besilate Tab"
First Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg)
Fisrt period TWLODrug
Also called "Twolion Tab"
First Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
Washout periodOther
7 days
Second period TWLO_CDrug
Also called "Dong-a Bepotastine Besilate Tab"
Second Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg)
Second period TWLODrug
Also called "Twolion Tab"
Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg)
| Study group | Role | What they receive |
|---|---|---|
| TWLO_C → TWLO | Experimental | TWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg) Receives: Drug: Fisrt period TWLO_C; Other: Washout period; Drug: Second period TWLO |
| TWLO → TWLO_C | Experimental | TWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg) Receives: Drug: Fisrt period TWLO; Other: Washout period; Drug: Second period TWLO_C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the plasma Concetration versus time curve(AUClast) of Bepotastine Besilate
Measured: Before administration ~ 12 hours
Peak Plasma Concentration(Cmax) of Bepotastine Besilate
Measured: Before administration ~ 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start23 Apr 2019
- Primary completion28 May 2019
- Study completion28 May 2019
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-dose, 2-sequence
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT03932435
- Sponsor's protocol ID
- TWLO_BE_01
- Status last verified
- Feb 2020
- First submitted
- 22 Apr 2019
- Last updated
- 10 Feb 2020
- 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 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03932435
- Acronym / sponsor ID
- TWLO_BE_01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 28 May 2019 (actual)
- First posted
- 30 Apr 2019 (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.
An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab" (Bepotastine Besilate 10mg) in Healthy Volunteers
Detailed description
- Study design: An open-Label, randomized, 2-sequence, 2-period, fasted condition, single-dose, per oral, cross-over study
- Administration method: The subject should maintain a minimum of 10 hours of empty stomach before administration, and give an oral dose of 1 tablets (Bepotastine Besilate 10 mg) with 150 mL of water at around 8 a.m. on the day of the test at room temperature. The test subject should not chew the drug or break it, but should swallow in whole with water. The difference in administration time between the test subjects is about one minute apart, considering the collection time.
- Wash out period: 7 days
- Blood collection time: Before the administration, 0.25, 0.5, 0.75, 1, 1.33, 1.67, 2, 3, 4, 6, 8, 12 hr after the administration (total 13 times)
- Analysis: Measurement of the concentration of an unchangeable substance of Bepotastine in plasma
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-dose, 2-sequence
| Arm | Type | Receives |
|---|---|---|
| TWLO_C → TWLO | Experimental | Drug: Fisrt period TWLO_C, Other: Washout period, Drug: Second period TWLOTWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg) |
| TWLO → TWLO_C | Experimental | Drug: Fisrt period TWLO, Other: Washout period, Drug: Second period TWLO_CTWLO_C: "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg), TWLO: "Twolion Tab" (Bepotastine Besilate 10mg) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A person who aged 19 or older at the time of screening
- No congenital or chronic diseases or pathological symptoms on screening
- A person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination
- BMI of 18 to 30 (BMI calculation: kg/m2)
- No history of gastrointestinal resection that may affect the absorption of drugs
Key exclusion criteria (13 listed)
- A person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to screening
- A person who uses drugs that can affect the study within 10 days before screening
- A person who is considered unsuitable to participate in the study by the investigator
- A person who has participated in other clinical trials within three months prior to the first administration of the IP
- A person who has had whole blood transfusion within 2 months or the apheresis within 2 weeks before screening
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 |
|---|---|---|
| Fisrt period TWLO_CAlso: "Dong-a Bepotastine Besilate Tab"First Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg) | Drug | TWLO_C → TWLO |
| Fisrt period TWLOAlso: "Twolion Tab"First Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg) | Drug | TWLO → TWLO_C |
| Washout period7 days | Other | TWLO → TWLO_C, TWLO_C → TWLO |
| Second period TWLO_CAlso: "Dong-a Bepotastine Besilate Tab"Second Period: Single oral administration of 1 tablet of "Dong-a Bepotastine Besilate Tab"(Bepotastine Besilate 10mg) | Drug | TWLO → TWLO_C |
| Second period TWLOAlso: "Twolion Tab"Second Period: Single oral administration of 1 tablet of "Twolion Tab"(Bepotastine Besilate 10mg) | Drug | TWLO_C → TWLO |
Primary outcome
Area Under the plasma Concetration versus time curve(AUClast) of Bepotastine Besilate
Time frame: Before administration ~ 12 hours
Peak Plasma Concentration(Cmax) of Bepotastine Besilate
Time frame: Before administration ~ 12 hours
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 10 Feb 2020.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 study testing Fisrt period TWLO_C, Fisrt period TWLO and Washout period 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 9 inclusion and 13 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 10 Feb 2020. 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.
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 Concetration versus time curve(AUClast) of Bepotastine Besilate (time frame: Before administration ~ 12 hours). 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 10 Feb 2020.