Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteers
Treatments
Other: Placebo 2
Drug: Lacosamide
Other: Placebo 3
Other: Placebo 4
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
Enrollment
33 patients
Sex
Male
Ages
18 to 45 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy Chinese or Japanese volunteers
Exclusion criteria
- Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)
Trial design
33 participants in 8 patient groups, including a placebo group
Lacosamide 100 mg, Japanese
Experimental group
Description:
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Treatment:
Drug: Lacosamide
Other: Placebo 3
Drug: Lacosamide
Drug: Lacosamide
Lacosamide 100 mg, Chinese
Experimental group
Description:
1 Lacosamide 100 mg tablet plus 3 placebo tablets
Treatment:
Drug: Lacosamide
Other: Placebo 3
Drug: Lacosamide
Drug: Lacosamide
Lacosamide 200 mg, Japanese
Experimental group
Description:
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Treatment:
Other: Placebo 2
Drug: Lacosamide
Drug: Lacosamide
Drug: Lacosamide
Lacosamide 200 mg, Chinese
Experimental group
Description:
2 Lacosamide 100 mg tablets plus 2 placebo tablets
Treatment:
Other: Placebo 2
Drug: Lacosamide
Drug: Lacosamide
Drug: Lacosamide
Lacosamide 400 mg, Japanese
Experimental group
Description:
4 Lacosamide 100 mg tablets
Treatment:
Drug: Lacosamide
Drug: Lacosamide
Drug: Lacosamide
Lacosamide 400 mg, Chinese
Experimental group
Description:
4 Lacosamide 100 mg tablets
Treatment:
Drug: Lacosamide
Drug: Lacosamide
Drug: Lacosamide
Placebo Comparator, Japanese
Placebo Comparator group
Description:
4 placebo tablets
Treatment:
Other: Placebo 4
Placebo Comparator, Chinese
Placebo Comparator group
Description:
4 placebo tablets
Treatment:
Other: Placebo 4
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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