NCT05519514

Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects

A Randomized, Open Label, Single Dose, Balanced, Two Treatment, Two Sequence, Four Period, Fully Replicate, Cross Over Bio-Equivalence Study Of Budesonide Prolonged Release Tablets 9 Mg Of Abbott India Ltd., With Cortiment® 9 Mg (Budesonide), Prolonged Release Tablets Of Ferring Pharmaceuticals Ltd., UK in Healthy Human Adult Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.

Conditions

• Healthy Subjects
• Human Volunteers
• Healthy Participants
• Bioequivalence

Interventions

Type	Name	Description
DRUG	Cortiment	Budesonide 9 mg prolonged release tablets
DRUG	Budesonide	Experimental (Budesonide 9 mg prolonged release tablets)

Timeline

• Start date: 2021-07-12
• Primary completion: 2021-08-08
• Completion: 2021-11-15
• First posted: 2022-08-29
• Last updated: 2022-08-29

Locations

1 site across 1 country: India