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A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects

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UCB

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Lacosamide (LCM) tablet
Drug: Lacosamide (LCM) dry syrup

Study type

Interventional

Funder types

Industry

Identifiers

NCT02972125
2016-002462-31 (EudraCT Number)
EP0059

Details and patient eligibility

About

This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet and Dry Syrup in Healthy Male Japanese Subjects

Enrollment

24 patients

Sex

Male

Ages

20 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subject is male and between 20 and 55 years of age (inclusive)
  • Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
  • Male subject confirms that when having sexual intercourse with a woman of childbearing potential, he will use condoms during the study and 1 week after the last dose of study drug

Exclusion criteria

  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
  • Subject has clinically relevant out-of-range values for hematology, and serum chemistry, or urinalysis variables at the Screening Visit.
  • Subject has any clinically significant abnormal physical examination (Screening Visit or Day -1) and vital signs (Screening Visit).
  • Subject has any clinically relevant ECG finding at the Screening Visit.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Treatment A - B
Experimental group
Description:
Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet), followed by a Wash-Out Period of at least 7 days and a single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup).
Treatment:
Drug: Lacosamide (LCM) dry syrup
Drug: Lacosamide (LCM) tablet
Treatment B - A
Experimental group
Description:
Single administration of the test drug (Treatment B, a single dose of LCM 100 mg given as dry syrup), followed by a Wash-Out Period of at least 7 days and a single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 100 mg tablet).
Treatment:
Drug: Lacosamide (LCM) dry syrup
Drug: Lacosamide (LCM) tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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