A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects

NCT ID: NCT03204474

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-08
• Study Completion Date: 2017-07-28

Brief Summary

The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.

Conditions

Healthy Male Chinese Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A - B

Single administration of the reference drug (Treatment A, a single dose of Lacosamide (LCM) 200 mg administered as 2 oral tablets \[100 mg each\]), 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 200 mg administered as intravenous infusion)

Group Type: EXPERIMENTAL

Lacosamide (LCM) tablet

Intervention Type: DRUG

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Lacosamide (LCM) solution for infusion

Intervention Type: DRUG

Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Treatment B - A

Single administration of the test drug (Treatment B, a single dose of LCM 200 mg administered as intravenous infusion), 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) 200 mg administered as 2 oral tablets \[100 mg each\])

Group Type: EXPERIMENTAL

Lacosamide (LCM) tablet

Intervention Type: DRUG

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Lacosamide (LCM) solution for infusion

Intervention Type: DRUG

Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Interventions

Lacosamide (LCM) tablet

Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg

Intervention Type: DRUG

Lacosamide (LCM) solution for infusion

Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Vimpat; Vimpat

Eligibility Criteria

Inclusion Criteria

• Subject is a Chinese male between 18 and 40 years of age
• 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

Clinically relevant

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

UCB (+1 844 599 2273)

Locations

Sp1043 001

Shanghai, , China

Countries

China

Other Identifiers

SP1043

Identifier Type: -

Identifier Source: org_study_id