Trial Details

None
Basic Information
Clinical ID c2303
Identifier ACTRN12622000579796
Trial Title A single dose, randomised, 2-period, 2-sequence, crossover, relative bioavailability study comparing 2 x 10 mg R-178 tablets with 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets administered orally in healthy participants under fasting conditions.
Trial URL Visit Original Page
Study Information
Study Results

No results available
Conditions 2-amino-1,7-dihydro-6H-purine-6-thione is indicated for the maintenance treatment of inflammatory bowel disease (Crohn's disease or ulcerative colitis).; 2-amino-1,7-dihydro-6H-purine-6-thione is indicated for the maintenance treatment of inflammatory bowel disease (Crohn's disease or ulcerative colitis).;Oral and Gastrointestinal - Crohn's disease;Oral and Gastrointestinal - Inflammatory bowel disease
Interventions Single dose, crossover study design whereby each participant receives the test formulation of 2 x 10 mg R-178 tablets on one occasion and the reference formulation 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets on one occasion with each dose separated by a two week washout period. The intervention for this trial is the test R-178 formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the oral dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Bathroom visits will be supervised during the first 5 hours. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 32 hours after dosing. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing and drugs of abuse test will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Both doses will be taken orally with 240 ml of water at ambient temperature. The 2-amino-1,7-dihydro-6H-purine-6-thione tablets must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Participant Information
Sponsor Zenith Technology Corporation Limited
City -
Country/Region New Zealand
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -