A Study to Investigate the Bioequivalence of Lacosamide Tablet (200mg) and Syrup (10mg/ml) in Healthy Chinese Male Subjects
NCT ID: NCT03086382
Last Updated: 2017-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2017-02-27
2017-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Treatment A - B
Single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions
Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
Lacosamide (LCM) syrup
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Treatment B - A
Single administration of Treatment B (single dose of LCM 200 mg given as syrup) under fasting conditions, followed by a Wash-Out Period of at least 7 days and a single administration of Treatment A (single dose of Lacosamide (LCM) 200 mg, given as 2 tablets of LCM 100 mg) under fasting conditions
Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
Interventions
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Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
Lacosamide (LCM) syrup
Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
Eligibility Criteria
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Inclusion Criteria
* Subject has no clinically significant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
* Subject confirms that during the study and for a period of 3 months after the final dose of study drug, when having sexual intercourse with a woman of childbearing potential, an acceptable birth control method will be used
Exclusion Criteria
* out of range values for hematology and clinical chemistry variables
* abnormality in physical examination or vital signs
* ECG finding Any clinical conditions that in the opinion of the investigator would make the subject unsuitable for the study
18 Years
40 Years
MALE
Yes
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 877 822 9493)
Locations
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Sp1001 001
Shanghai, , China
Countries
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Other Identifiers
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SP1001
Identifier Type: -
Identifier Source: org_study_id
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