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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT02466503
Brief Summary:
The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.
Detailed Description:
A pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, crossover, comparative bioavailability study for test drug Synflutide HFA 250/25 Inhaler and reference drug SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block. Fifty healthy, male and female volunteers, 20-65 years of age, with a body mass index (BMI) within 18.0-30.0 kg/m2, inclusive, will be enrolled. A single dose of 4 puffs (eq. to fluticasone propionate 1000μg+salmeterol 100μg from valve) in each study period. Plasma samples will be assayed for fluticasone propionate and salmeterol using a validated analytical method according to the principles of Good Laboratory Practice.
Study:
NCT02466503
Study Brief:
Protocol Section:
NCT02466503