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Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Lacosamide infusion (Drug); Lacosamide oral (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: UCB Pharma SA

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

Clinical Details

Official title: A Single Center Open-label, Randomized, Single-dose, 3-way Crossover Study to Compare the Safety, Tolerability, and Pharmacokinetics of Lacosamide Administered as Oral Tablet or Intravenous Infusion in Healthy Japanese Subjects

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Maximum plasma concentration of Lacosamide (Cmax) after oral and intravenous administration of Lacosamide

Area under the plasma concentration-time curve from zero up to the last analytically quantifiable concentration of Lacosamide (AUC 0-t) after oral and intravenous administration of Lacosamide

Secondary outcome:

Area under the plasma concentration-time curve from zero up to infinity (AUC) after oral and intravenous administration of Lacosamide

Time to reach a maximum plasma concentration (tmax) after oral and intravenous administration of Lacosamide

Mean residence time (MRT) after oral and intravenous administration of Lacosamide

Rate constant of elimination (λz) after oral and intravenous administration of Lacosamide

Terminal half-life (t1/2) after oral and intravenous administration of Lacosamide

Apparent total body clearance (CL/F) after oral administration of Lacosamide

Total body clearance (CL) after intravenous administration of Lacosamide

Apparent volume of distribution (Vz/F) after oral administration of Lacosamide

Volume of distribution (Vz) after intravenous administration of Lacosamide

Eligibility

Minimum age: 20 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy Japanese male and female volunteers with the age between 20 and 55 years old

Exclusion Criteria:

- Subject has participated or is participating in any other clinical studies of

investigational drug or another investigational medical product within the last 3 months

- Subject has a history (within 6 months) before screening visit of chronic alcohol

and/or drug abuse and/or has smoked and/or has a history or presence of cardiovascular, respiratory, hepatic, renal, GI, endocrinological, or neurological disorders

- Subject has a history of suicide attempt or current active suicidal ideation

- Subject has experienced a myocardial infarction and/or made a blood donation or any

other blood loss more than 400 ml in the last 3 months

- Subject is pregnant or nursing

- Subject is not healthy (eg, taking any drug treatments, having any medical or

emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters and/or was positive for HIV, HBsAg, HCV)

- Subject has an excessive use of alcohol or/and cigarettes and/or caffeine and/or

abnormal diet and/or has taken grapefruit or grapefruit drink within 7 days before intake of Investigational Medicinal Product (IMP)

- Subject has a clinically significant abnormality in the 12-lead Electrocardiogram

(ECG)

- Subject is having clinically relevant drug hypersensitivity to any components of the

investigational medicinal product

Locations and Contacts

001, Harrow, Middlesex, United Kingdom
Additional Information

Starting date: November 2013
Last updated: September 11, 2014

Page last updated: August 23, 2015

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