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CompletedNCT02395926Updated Mar 24, 2015

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 interventional study of Choline CR 600mg and Gliatilin 400mg in Healthy Male, sponsored by Hyundai Pharmaceutical Co., LTD.. Completed. Open to male participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Hyundai Pharmaceutical Co., LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 55 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Healthy Male
03

In context

Lead sponsor

Hyundai Pharmaceutical Co., LTD. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male subjects between the ages of 20 and 55 years, inclusive
  2. BMI>=19kg/m2, \<=27kg/m2

    *body mass index (kg/m2) = weight (kg)/ [(height (m)2)

  3. Voluntary written consent by the parties that the ability and willingness to participate during the entire period of the test

Exclusion criteria

Exclusion Criteria:

  1. Subjects who has history or clinically significant disease about liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood•tumor type, cardiovascular disease.
  2. 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

  3. 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
  4. Subjects with known for hypersensitivity reaction to components of the investigational drug
  5. Subjects who has history of drug abuse, shows positive in urine drug screening test
  6. 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
  7. Participation in any clinical investigation within 60days prior to study medication dosing
  8. Subjects with whole blood donation within 60days, component blood donation within 30days
  9. Caffeine-containing beverages (coffee, tea, cola) intake or grapefruit / orange juice who exceed the average daily intake of 4 cups.
  10. Subjects who intake average alcohol consumption per week exceeds 140g or cannot be a non-alcohol during the hospital stay.
  11. Subjects who exceed the average daily smoke of 10 cigarettes or cannot be a non-smoking during the hospital stay
  12. Subjects who cannot limit the choline-containing food (liver, cocoa, bean, chocolate, otmil etc), from admitted to the hospital the day before
  13. Subjects who shows positive in serum test (hepatitis B, C, HIV)
  14. 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    R

    Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00

    Drug: Gliatilin 400mg

  • Experimental
    T1

    HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00

    Drug: Choline CR 600mg

  • Experimental
    T2

    HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m.

    Drug: Choline CR 600mg

Interventions

  • DrugCholine CR 600mg

    HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00

  • DrugGliatilin 400mg

    Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00

  • DrugCholine CR 600mg

    HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m.

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: in 24hr after administration

  2. AUClast

    Time frame: in 24hr after administration

Secondary outcomes

  1. baseline-corrected Cmax

    Time frame: in 24hr after administration and before administration

  2. baseline-corrected AUClast

    Time frame: in 24hr after administration and before administration

  3. Tmax

    Time frame: in 24hr after administration and before administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02395926
Lead sponsor
Hyundai Pharmaceutical Co., LTD.
Responsible party
Sponsor
First posted
Mar 24, 2015
Start date
Oct 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Mar 24, 2015

Study contacts

Jungryul Kim, Ph.D
principal investigator · Samsung seoul hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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