Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04520360
Brief Summary:
This study is designed to examine the relative bioavailability of three carisbamate formulations (Oral Suspension Type 1, Oral Suspension Type 2, and a 300 mg Oral Tablet) and to assess the effect of food on the oral bioavailability of the Oral Suspension Type 2 and the 300 mg Oral Tablet.
Detailed Description:
This is a single center, open-label, randomized, 5-period, 10-sequence study designed to assess each treatment in 30 healthy subjects enrolled in the study. The five treatments tested using a single oral administration will be: (1) Oral Suspension Type 1, 300 mg Oral Tablet, Oral Suspension Type 2 all under fasted conditions and (2) Oral Suspension Type 2, 300 mg Oral Tablet under fed conditions. Each dose is followed by at least a seven-day washout period. The sequence and period arrangement will be constructed based on the Williams design to ensure the study is balanced with respect to first-order carry-over effects.
Study:
NCT04520360
Study Brief:
Protocol Section:
NCT04520360