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 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT05532267
Brief Summary:
To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each containing Ciprofloxacin 750 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.
Detailed Description:
Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 7 days.
Ciprofloxacin plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.
Study:
NCT05532267
Study Brief:
Protocol Section:
NCT05532267