This is a single-center, randomized, open-label, three-period, dual Latin square crossover study. Primary Objective: 1. To evaluate the oral relative bioavailability of HR19042 Capsules compared with budesonide delayed-release capsules (Tarpeyo®) and budesonide enteric-coated capsules (Budenofalk®). Secondary Objective 2. To assess safety following administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
18
In each period under fasting conditions, subjects received oral administration of either HR19042 Capsule 16 mg, Tarpeyo® 16 mg, or Budenofalk® 15 mg.
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time frame: From Day 1 up to Day 8
Incidence of treatment emergent AEs (TEAEs)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.