In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

Overview

This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

Full Title of Study: “A Single Part, Four Period Sequential, Open Label Study Designed to Evaluate the In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 29, 2019

Detailed Description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. For each treatment period, subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site until 24 h post-dose. Following Period 2, there will be an interim analysis and review of safety and scintigraphy data from dosed regimens in order to determine which formulations will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days post-final dose to ensure the ongoing wellbeing of the subjects.

Interventions

  • Drug: Budesonide
    • single dose of 2 mg oral suspension formulation administered orally under fasting conditions

Arms, Groups and Cohorts

  • Experimental: Budesonide: Formulation 1
    • single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions
  • Experimental: Budesonide: Formulation 2
    • single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions
  • Experimental: Budesonide: Formulation 3
    • single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions
  • Experimental: Budesonide: Formulation 4
    • single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions

Clinical Trial Outcome Measures

Primary Measures

  • Total oesophageal transit time
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
  • Time at which 10% radiolabel administered has arrived in the oesophagus from the mouth (T10%) (min)
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
  • Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min)
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
  • Time at which the amount of radiolabel present in the oesophagus peaks (Tmax) (min)
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
  • Time at which 90% of the radiolabel present at Tmax has left the oesophagus (T90%) (min)
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
  • Total amount of radiolabel present in the oesophagus and the three regions over time
    • Time Frame: During procedure
    • A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.

Secondary Measures

  • Number of adverse events
    • Time Frame: throughout the study, approximately 13 weeks
    • Number of adverse events will be provided to get additional information on the safety and tolerability of budesonide suspension formulations after oral administration.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy males and females aged 30 to 65 years – Body mass index 18.0 to 32.0 kg/m2 Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sandoz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sandoz, Study Director, Sandoz

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