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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT02750332
Brief Summary:
The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).
Detailed Description:
The specific aim is to conduct a randomized, single dose, two-period crossover bioavailability study in at least 16 healthy male and female subjects at a single study center to evaluate the in vivo performance of Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions.
The study in healthy male and female volunteers is designed to establish a pharmacokinetic (PK) profile under fed and fasting conditions for the orally administered Test Product, Nitisinone 10 mg Tablets.
A total of 20 healthy female and male volunteers (age 18 to 55 years old) will be entered into the study. Volunteers will be determined to be free of significant medical conditions as assessed by medical history, physical examination, and blood and urine tests. Volunteers will be randomly allocated to receive the Test Product under fasting or fed conditions.
There will be a minimum 23 calendar days washout between treatments. Blood samples will be collected at pre-dose (0 hours) and at 15 minutes, 30 minutes, 1 hour, 2 hours, 2 hours and 30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours post-dose (total: 21 samples per treatment period).
Study:
NCT02750332
Study Brief:
Protocol Section:
NCT02750332