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 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT02141061
Brief Summary:
This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.
Study:
NCT02141061
Study Brief:
Protocol Section:
NCT02141061