Comparative bioavailability assessment between 2 x 10 mg R-178 tablets and 2 x 10 mg 2-amino-1,7-dihydro-6H-purine-6-thione tablets administered orally in healthy participants under fasting conditions.
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.
Zenith Technology Corporation Limited
14 participants
Jul 18, 2022
Interventional
Conditions
Summary
The objective of this study is to evaluate the bioequivalence of the test formulation R-178 tablets relative to that of the reference formulation 2-amino-1,7-dihydro-6H-purine-6-thione tablets in fasting conditions. In this study we will measure how much 2-amino-1,7-dihydro-6H-purine-6-thione is absorbed into the bloodstream and compare the concentrations between the test and reference formulations.
Eligibility
Inclusion Criteria7
- Healthy participants.
- Aged between 18 and 55
- Non-smoker
- BMI between 18 and 30
- Healthy individuals in good health as determined by medical history, physical examination, ECG, blood pressure and laboratory tests
- The absence of mental illness requiring medication or treatment by a physician.
- Able to provide written informed consent
Exclusion Criteria12
- Concomitant drug therapy of any kind
- Any history of mental illness requiring medication or treatment by a physician.
- A deficient, low or intermediate TPMT ensyme activity by means of phenotyping found during medical screening
- History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- History of Gilbert's Syndrome or Gout
- Sensitive to the study drug
- History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- Smoker (anyone who has smoked in the last 6 months)
- Participants of child- bearing potential who are pregnant and/or breastfeeding
- History of alcohol abuse or dependency
- Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study
- Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
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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.
Locations(1)
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ACTRN12622000579796