HealthyPhase 1NCT01723891
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
A Phase 1 study testing Surfolase capsule and HT-002-01 in people with Healthy, run by Hyundai Pharmaceutical Co., LTD. at 1 site in South Korea.
Trial summary
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Surfolase capsule and HT-002-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to not given
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
- Volunteers without apriority of chronic disease
- Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
- Volunteers who comply with the protocol, understand and sign an informed consent
Who cannot join
- Sensitive response to acebrophylline and xanthine
- Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
- Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
- Known history of gastrointestinal disease which affects the absorption of medicine.
- Excluded by screening tests
- Upper limit of AST, ALT>1.25 times Upper limit of total bilirubin>1.5 times
Show all 14Show fewer
- Estimated GFR<80mL/min/1.73m2)
- systolic blood pressure < 90 or > 150, diastolic blood pressure <50 or >100
- Known history of drug abuse
- caffeine>5cups/day, alcohol>210g/week, 10 more cigarettes/day
- Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
- Participation in any clinical investigation within 60 days prior to study start
- Donation of blood within 60 days, donation of component blood within 30days
- Judged by the investigators to be undesirable as subjects
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul, Seoul, 120-752
About this study
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.
- Conditions
- Healthy
- Being tested
- Surfolase capsule, HT-002-01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfolase capsuleDrug
HT-002-01Drug
| Study group | Role | What they receive |
|---|---|---|
| Surfolase capsule & HT-002-01 | Active comparator | Not described Receives: Drug: Surfolase capsule; Drug: HT-002-01 |
| HT-002-01 & Surfolase capsule | Active comparator | Not described Receives: Drug: Surfolase capsule; Drug: HT-002-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCt, Cmax
Secondary outcomes (1)
AUCinf, Tmax, t1/2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startNov 2012
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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723891
- Sponsor's protocol ID
- HT-002-01
- Status last verified
- Nov 2012
- First submitted
- 6 Nov 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01723891
- Acronym / sponsor ID
- HT-002-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hyundai Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- First posted
- 8 Nov 2012 (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 to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfolase capsule & HT-002-01 | Active comparator | Drug: Surfolase capsule, Drug: HT-002-01 |
| HT-002-01 & Surfolase capsule | Active comparator | Drug: Surfolase capsule, Drug: HT-002-01 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
- Volunteers without apriority of chronic disease
- Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
- Volunteers who comply with the protocol, understand and sign an informed consent
Key exclusion criteria (14 listed)
- Sensitive response to acebrophylline and xanthine
- Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
- Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
- Known history of gastrointestinal disease which affects the absorption of medicine.
- Excluded by screening tests
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 |
|---|---|---|
| Surfolase capsule | Drug | HT-002-01 & Surfolase capsule, Surfolase capsule & HT-002-01 |
| HT-002-01 | Drug | HT-002-01 & Surfolase capsule, Surfolase capsule & HT-002-01 |
Primary outcome
AUCt, Cmax
1 secondary outcome
AUCinf, Tmax, t1/2
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 8 Nov 2012.
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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 Surfolase capsule and HT-002-01 in people with Healthy, run by Hyundai Pharmaceutical 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 4 inclusion and 14 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 8 Nov 2012. 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?
AUCt, Cmax. 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 8 Nov 2012.