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Completed

NCT Number: NCT05429775

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sandoz Investigative Site

Nottingham, England, NG11 6JS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Budesonide

Drug

single dose of 2 mg oral suspension formulation administered orally under fasting conditions

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2022
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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