NCT02395926

To Evaluate Safety and the Pharmacokinetic Characteristics After Oral Administration of HT-003 Compared With Choline Alfoscerate Capsule in Healthy Adult Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hyundai Pharmaceutical Co., LTD. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Male

Interventions

Type	Name	Description
DRUG	Choline CR 600mg	HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00
DRUG	Gliatilin 400mg	Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00
DRUG	Choline CR 600mg	HT-003 600mg\*2tab, administration 1 times per 1 day 8:00 a.m.

Timeline

• Start date: 2013-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-03-24
• Last updated: 2015-03-24