Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions
Unknown statusEarly phase 1NCT06249581
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Exploratory, single-dose, open-label, pharmacokinetic study to establish uptake, plasma levels safety and tolerability of orally administered AUX-001 on an empty stomach (i.e, fasting) as well as after a meal (i.e. fed) in healthy volunteers.
Study details
- Official title
- Pharmacokinetics of Nicorandil 40 mg Extended-Release Capsules: A Single-Dose, Open-Label, Randomized, Two-Sequence, Two-Treatment, Two-Period Crossover Study in Healthy Subjects Under Fasting and Fed Conditions
- Conditions
- Interventions
- Drug: AUX-001 40mg once-daily
- Sponsor
- Auxilius Pharma sp.z.o.o.
- Start date
- 2023-11-27
- Primary completion
- 2024-02-08
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Portugal
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Free written informed consent signed and dated prior to any procedure required by the study. 2. Male or female subject between 18 and 55years, inclusive, at the time of signing the informed consent. 3. Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive. 4. No clinically relevant diseases captured in medical history. 5. No clinically relevant abnormalities on physical examination. 6. No clinically relevant abnormalities on vital signs. 7. No clinically relevant abnormalities on 12-lead EKG. 8. No clinically relevant abnormalities on laboratory tests. 9. Neg. test results on anti-HIV-1Ab and anti-HIV-2Ab, HbsAG and anti-HCVAb 10. Non-smoker or ex-smoker 11. Willingness to accept and comply with all study procedures and restrictions. 12. Female subject of a) non-child-bearing potential or b) of childbearing potential and agrees to use an accepted, highly effective contraceptive method until the end of the study. Exclusion Criteria: 1. Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients. 2. Known severe hypersensitivity reaction to any other drug. 3. Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject's safety. 4. History of glucose-6-phosphate dehydrogenase deficiency. 5. History of severe hypotension or shock. 6. History of acute pulmonary edema, heart failure, coronary artery disease or myocardial infarction. 7. History of orthostatic hypotension, collapse, fainting, syncope, or vasovagal reaction. 8. History of substance or alcohol abuse within the previous 2 years. 9. Use of contact lenses. 10. SBP \<95 mmHg and/or DBP \<45 mmHg. 11. Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range. 12. Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2. 13. Positive result in drugs-of-abuse or ethanol tests. 14. Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months. 15. Average weekly alcohol consumption of \>14 units for males and \>7 units for females within the previous 6 m…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06249581