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
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.
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.
BMI>=19kg/m2, \<=27kg/m2
*body mass index (kg/m2) = weight (kg)/ [(height (m)2)
Exclusion Criteria:
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
Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00
Drug: Gliatilin 400mg
HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00
Drug: Choline CR 600mg
HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m.
Drug: Choline CR 600mg
HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00
Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00
HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m.
Cmax
Time frame: in 24hr after administration
AUClast
Time frame: in 24hr after administration
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
No study locations are listed for this record.
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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Hyundai Pharmaceutical Co., LTD.