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

NCT05519514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-08-29

No results posted yet for this study

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

DRUG

Cortiment

Budesonide 9 mg prolonged release tablets

DRUG

Budesonide

Experimental (Budesonide 9 mg prolonged release tablets)

Sponsors & Collaborators

Principal Investigators

  • Dr. Shivani Acharya, MD pharmacology · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-12
Primary Completion
2021-08-08
Completion
2021-11-15

Countries

  • India

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519514 on ClinicalTrials.gov