Lacosamide
DrugLacosamide 50 mg, tablet, once in the morning on Day 1
Other names: Vimpat®
NCT Number: NCT01450111
Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects.
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Notify Me20 year–45 year
Male
Interventional
Phase 1
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lacosamide 50 mg, tablet, once in the morning on Day 1
Other names: Vimpat®
Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time frame: Urine samples were collected 0 - 4 hr, 4 - 8 hr, 8 - 12 hr, 12 - 24 hr, 24 - 48 hr, 48 - 72 hr, 72 - 96 hr after administration at Day 1 and Day 9
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
UCB Pharma
Industry
Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single/Repeated Dose Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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