Healthy MalePhase 1NCT02395926
To Evaluate Safety and the Pharmacokinetic Characteristics After Oral Administration of HT-003 Compared With Choline Alfoscerate Capsule in Healthy Adult Male Volunteers
A Phase 1 study testing Choline CR 600mg and Gliatilin 400mg in people with Healthy Male, run by Hyundai Pharmaceutical Co., LTD..
Trial summary
Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine glycerophosphate. 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 Male
- What is being tested?
- Choline CR 600mg and Gliatilin 400mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 20 and 55 years, inclusive
- BMI>=19kg/m2, <=27kg/m2
- body mass index (kg/m2) = weight (kg)/ [(height (m)2)
- Voluntary written consent by the parties that the ability and willingness to participate during the entire period of the test
Who cannot join
- Subjects who has history or clinically significant disease about liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood•tumor type, cardiovascular disease.
- A GFR of less than 60ml/min person, calculated by the MDRD (Modification of Diet in Renal Disease)
- ※ MDRD equation (mL/min/1.73m2) : GFR = 175 x Scr-1.154 x age-0.203
- Systolic blood pressure less than 90 mmHg in vital signs is 150 mmHg or diastolic blood pressure less than 50 mmHg or higher or numerical characters shown equal to at least 100 mmHg
- Subjects with known for hypersensitivity reaction to components of the investigational drug
- Subjects who has history of drug abuse, shows positive in urine drug screening test
Show all 15Show fewer
- Use of any prescription medication within 14 days prior to study medication dosing or use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- Participation in any clinical investigation within 60days prior to study medication dosing
- Subjects with whole blood donation within 60days, component blood donation within 30days
- Caffeine-containing beverages (coffee, tea, cola) intake or grapefruit / orange juice who exceed the average daily intake of 4 cups.
- Subjects who intake average alcohol consumption per week exceeds 140g or cannot be a non-alcohol during the hospital stay.
- Subjects who exceed the average daily smoke of 10 cigarettes or cannot be a non-smoking during the hospital stay
- Subjects who cannot limit the choline-containing food (liver, cocoa, bean, chocolate, otmil etc), from admitted to the hospital the day before
- Subjects who shows positive in serum test (hepatitis B, C, HIV)
- Subjects with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
About this study
Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell membrane play and acetylcholine receptor function secondary symptoms caused by cerebrovascular deficiency and indirectly through activation of metabolism, has a degenerative effect on the brain organic mental syndrome.
Currently marketed oral choline alfoscerate received a geriatric cognitive impairment, secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when considering optimal convenience and efficiency of the drug in patients with the development of sustained release formulations that can be maintained for a long period of time, a certain concentration is required. Accordingly, the modern drug by reducing the frequency of administration a day circuit is to develop a sustained release formulation of choline alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a time (600 mg x 2) can be taken one day to 1200 mg is required by taking.
Therefore, for the development of sustained release formulation, the test in healthy adult male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1 day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety of a single dose should be evaluated when compared.
- Conditions
- Healthy Male
- Being tested
- Choline CR 600mg, Gliatilin 400mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choline CR 600mgDrug
HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00
Gliatilin 400mgDrug
Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00
Choline CR 600mgDrug
HT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m.
| Study group | Role | What they receive |
|---|---|---|
| R | Active comparator | Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00 Receives: Drug: Gliatilin 400mg |
| T1 | Experimental | HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00 Receives: Drug: Choline CR 600mg |
| T2 | Experimental | HT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m. Receives: Drug: Choline CR 600mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: in 24hr after administration
AUClast
Measured: in 24hr after administration
Secondary outcomes (3)
baseline-corrected Cmax
Measured: in 24hr after administration and before administration
baseline-corrected AUClast
Measured: in 24hr after administration and before administration
Tmax
Measured: in 24hr after administration and before administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MaleStudies 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
- Investigators
- Jungryul Kim, Ph.D, Principal investigator, Samsung seoul hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395926
- Sponsor's protocol ID
- HT-003-01
- Status last verified
- Feb 2015
- First submitted
- 10 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Safety and the Pharmacokinetic Characteristics After Oral Administration of HT-003 Compared With Choline Alfoscerate Capsule in Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT02395926
- Acronym / sponsor ID
- HT-003-01
- Conditions
- Healthy Male
- 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
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Mar 2015 (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.
Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell membrane play and acetylcholine receptor function secondary symptoms caused by cerebrovascular deficiency and indirectly through activation of metabolism, has a degenerative effect on the brain organic mental syndrome.
Currently marketed oral choline alfoscerate received a geriatric cognitive impairment, secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when considering optimal convenience and efficiency of the drug in patients with the development of sustained release formulations that can be maintained for a long period of time, a certain concentration is required. Accordingly, the modern drug by reducing the frequency of administration a day circuit is to develop a sustained release formulation of choline alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a time (600 mg x 2) can be taken one day to 1200 mg is required by taking.
Therefore, for the development of sustained release formulation, the test in healthy adult male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1 day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety of a single dose should be evaluated when compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R | Active comparator | Drug: Gliatilin 400mgGliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00 |
| T1 | Experimental | Drug: Choline CR 600mgHT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00 |
| T2 | Experimental | Drug: Choline CR 600mgHT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m. |
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 ages of 20 and 55 years, inclusive
- BMI>=19kg/m2, <=27kg/m2
- body mass index (kg/m2) = weight (kg)/ [(height (m)2)
- Voluntary written consent by the parties that the ability and willingness to participate during the entire period of the test
Key exclusion criteria (15 listed)
- Subjects who has history or clinically significant disease about liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood•tumor type, cardiovascular disease.
- A GFR of less than 60ml/min person, calculated by the MDRD (Modification of Diet in Renal Disease)
- ※ MDRD equation (mL/min/1.73m2) : GFR = 175 x Scr-1.154 x age-0.203
- Systolic blood pressure less than 90 mmHg in vital signs is 150 mmHg or diastolic blood pressure less than 50 mmHg or higher or numerical characters shown equal to at least 100 mmHg
- Subjects with known for hypersensitivity reaction to components of the investigational drug
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 |
|---|---|---|
| Choline CR 600mgHT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00 | Drug | T1 |
| Gliatilin 400mgGliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00 | Drug | R |
| Choline CR 600mgHT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m. | Drug | T2 |
Primary outcome
Cmax
Time frame: in 24hr after administration
AUClast
Time frame: in 24hr after administration
3 secondary outcomes
baseline-corrected Cmax
Time frame: in 24hr after administration and before administration
baseline-corrected AUClast
Time frame: in 24hr after administration and before administration
Tmax
Time frame: in 24hr after administration and before administration
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 24 Mar 2015.
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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.
Jungryul Kim, Ph.D principal investigator
Samsung seoul hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Choline CR 600mg and Gliatilin 400mg in people with Healthy Male, run by Hyundai 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 4 inclusion and 15 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 24 Mar 2015. 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?
Cmax (time frame: in 24hr after administration). 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 24 Mar 2015.