NCT02466347

Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block

A Single-Dose, Randomized, Open-Label, Crossover, Pivotal, Comparative Bioavailability Study of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in Healthy Volunteers Without Charcoal Block

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Intech Biopharm Ltd. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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 without 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 without 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.

Conditions

• Asthma
• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Fluticasone propionate	Inhaled corticosteroid, pMDI
DRUG	Salmeterol (as xinafoate)	Long Acting Beta-agonist (LABA), pMDI

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2015-06-09
• Last updated: 2016-07-26

Locations

1 site across 1 country: Taiwan