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An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic（PK）Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions.

NCT05788159 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-03-28

No results posted yet for this study

Summary

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Two-way Crossover, Oralcomparative Pharmacokinetic（PK）Study of Lacosamide Extended-Release Tablets , Adult, Human Subjects Under Fasting Conditions.

Main purpose:

To the Overseas Pharmaceutical,Ltd. Developed lacoxamide slow-release tablets (specification: 100mg) for the test preparation, UCB produced rasoxamide tablets (trade name: VIMPAT®, specification: 50mg) for the reference preparation, compare the fasting state of oral test preparation and reference preparation in Chinese healthy subjects blood concentration and main pharmacokinetic parameters, to evaluate the biological equivalence of test preparation and reference preparation.

Secondary objective:

To evaluate the safety of the test sustained-release tablets and reference tablets in the healthy Chinese subjects.

Conditions

Interventions

DRUG

Lacosamide Tablets

Reference preparation (R): Lacosamide Tablets Specification: 50mg/tablet Lot No.: 7883201 Content: 50mg/tablet Expiration date: September 2026 Storage condition: not more than 30C in airtight storage Manufacturer: Aesica Pharmaceuticals GmbH

DRUG

Lacosamide extended release tablets

Test preparation (T): Lacosamide extended release tablets Specification: 100mg/tablet Lot number: 22121301 Content: 100mg/tablet Expiration date: December 12, 2024 Storage conditions: Store at 20℃\~25℃, short-term can be at 15C\~30℃ Manufacturer: Overseas Pharmaceutical,Ltd.

Sponsors & Collaborators

  • Beijing Capton Pharmaceutical Technology Development Co., LTD

    collaborator UNKNOWN

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-06-30
Completion
2023-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05788159 on ClinicalTrials.gov