A Multicentre, Randomised, Controlled, Observer-Blind Study to Evaluate Safety and Duration in Stomach of Modified Release Prototype Capsules in Healthy Adults
- Conditions
- on-adherence to medicinesMetabolic and Endocrine - Normal metabolism and endocrine development and functionNon-adherence to medicines
- Registration Number
- ACTRN12618000991213
- Lead Sponsor
- yndra Australia Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1) Healthy male and female subjects
2) Body mass index of 18.0 to 30.0 kg/meters-squared
3) Suitable scores for two swallowing questionnaires
4) Demonstrate normal swallowing and gastrointestinal passage of capsules, as assessed while undergoing imaging studies
5) Must provide written informed consent
1) Participants who have previously been enrolled in this study
2) History of any drug or alcohol abuse in the past 2 years
3) Current smokers and those who have smoked within the past 12 months
4) Individuals with clinically significant medical history relating to the gastrointestinal tract and potential complications, thereof
5) Individuals with a positive test for HIV, hepatitis B or hepatitis C
6) Serious adverse reaction or serious hypersensitivity to components of the study formulations or patency capsule
7) Individuals who have received any experimental agent within 30 days (or 5 half-lives), whichever is longer, prior to the date of dosing
8) Individuals with contraindication to MRI imaging
9) Individuals with functional constipation, irritable bowel, or functional diarrheoa, as evaluated by standardized questionnaire
10) Individuals with contraindications to elective X-ray based on known or expected radiation exposure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method