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:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT01443169
Brief Summary:
This study is an open-label, single dose, randomized, 5-period, 5-treatment, 4-sequence cross-over with a fixed 5th treatment arm. Subjects will receive in a randomized sequence a 330 mg CR tablet with fast in vitro dissolution rate, a 330 mg CR tablet with slow in vitro dissolution rate, a heavier 330 mg CR tablet with fast in vitro dissolution rate or a 330 mg market image reference CR tablet. Subjects will receive a 300mg IR formulation in the 5th period to to estimate and compare the % of dose absorbed versus time profile for the three CR prototype tablets and the CR reference tablet.
Study:
NCT01443169
Study Brief:
Protocol Section:
NCT01443169