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Trial record 90 of 1357 for:    Area Under Curve AND tablet

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

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ClinicalTrials.gov Identifier: NCT02972125
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Lacosamide (LCM) tablet Drug: Lacosamide (LCM) dry syrup Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study to Investigate the Bioequivalence Between Lacosamide Tablet and Dry Syrup in Healthy Male Japanese Subjects
Study Start Date : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Treatment A - B
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).
Drug: Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Drug: Lacosamide (LCM) dry syrup
Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup

Experimental: Treatment B - A
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).
Drug: Lacosamide (LCM) tablet
Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet

Drug: Lacosamide (LCM) dry syrup
Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup




Primary Outcome Measures :
  1. Maximum concentration (Cmax) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  2. Area under the curve from 0 to time of last quantifiable concentration (AUC(0-t)) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]

Secondary Outcome Measures :
  1. Area under the curve from zero up to infinity (AUC) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  2. Apparent total body clearance (CL/F) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  3. Apparent volume of distribution (Vz/F) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  4. Mean residence time (MRT) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  5. Time of observed Cmax (tmax) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  6. Terminal elimination half-life (t1/2) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]
  7. First order terminal elimination rate constant (Lambda z) [ Time Frame: Blood samples are collected at predose and 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, and 72 hours after dosing ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972125


Locations
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United Kingdom
Ep0059 001
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
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Study Director: UCB Cares +1 877 822 9493 (UCB)

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Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02972125     History of Changes
Other Study ID Numbers: EP0059
2016-002462-31 ( EudraCT Number )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Lacosamide
Bioequivalence
Dry Syrup

Additional relevant MeSH terms:
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Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action