HealthyPhase 1NCT01925313
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers
A Phase 1 study testing CJ-30044 and TALION TAB. 10mg in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
Study objectives To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers. To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CJ-30044 and TALION TAB. 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to May 2013
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers in the age between 20 and 45 years old
- BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
- Subject with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
- Willing to adhere to protocol requirements and sign a informed consent form
Who cannot join
- History of clinically significant allergies, including Bepotastine.
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
- Clinical laboratory test values are outside the accepted normal range
- AST or ALT >1.25 times to normal range
Show all 21Show fewer
- Total bilirubin >1.5 times to normal range
- Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
- Clinically significant vital sign
- SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
- DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
- History of drug abuse or positive urine screen for drugs
- History of caffeine, alcohol, smoking abuse
- caffeine > 5 cups/day
- alcohol > 210g/week
- smoking > 10 cigarettes/day
- Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
- Participated in a previous clinical trial within 60 days prior to dosing
- Donated blood within 60 days prior to dosing
- Subjects considered as unsuitable based on medical judgement by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- CJ-30044, TALION TAB. 10mg
- Keywords
- Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-30044Drug
20.51mg a day,PO,QD
TALION TAB. 10mgDrug
10mg a day,PO,BID
| Study group | Role | What they receive |
|---|---|---|
| CJ-30044 | Experimental | Not described Receives: Drug: CJ-30044 |
| TALION TAB. 10mg | Active comparator | Not described Receives: Drug: TALION TAB. 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast and Peak plasma concentration (Cmax) of Bepotastine
Measured: Blood sampling up to 36hs post dose.
Secondary outcomes (1)
AUCinf, Tmax, T1/2 of Bepotastine
Measured: Blood sampleing up to 36hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionMay 2013
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.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- 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
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-Su Park, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925313
- Sponsor's protocol ID
- CJ_BEP_101
- Status last verified
- Dec 2012
- First submitted
- 15 Aug 2013
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT01925313
- Acronym / sponsor ID
- CJ_BEP_101
- Conditions
- Healthy
- Keywords
- Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Aug 2013 (estimated)
- 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.
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-30044 | Experimental | Drug: CJ-30044 |
| TALION TAB. 10mg | Active comparator | Drug: TALION TAB. 10mg |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers in the age between 20 and 45 years old
- Subject with no history of any significant chronic disease
- Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
- Willing to adhere to protocol requirements and sign a informed consent form
Key exclusion criteria (21 listed)
- History of clinically significant allergies, including Bepotastine.
- History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
- Clinical laboratory test values are outside the accepted normal range
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 |
|---|---|---|
| CJ-3004420.51mg a day,PO,QD | Drug | CJ-30044 |
| TALION TAB. 10mg10mg a day,PO,BID | Drug | TALION TAB. 10mg |
Primary outcome
AUClast and Peak plasma concentration (Cmax) of Bepotastine
Time frame: Blood sampling up to 36hs post dose.
1 secondary outcome
AUCinf, Tmax, T1/2 of Bepotastine
Time frame: Blood sampleing up to 36hrs post dose
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 19 Aug 2013.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
Min-Su Park, PhD principal investigator
Severance Hospital
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 CJ-30044 and TALION TAB. 10mg in people with Healthy, run by HK inno.N Corporation 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 5 inclusion and 21 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 19 Aug 2013. 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?
AUClast and Peak plasma concentration (Cmax) of Bepotastine (time frame: Blood sampling up to 36hs post dose.). 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 19 Aug 2013.