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Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions

NCT06249581 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-02-12

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Stable Angina

Interventions

DRUG

AUX-001 40mg once-daily

AUX-001 (extended-release nicorandil) 40mg QD (once-daily)

Sponsors & Collaborators

  • Auxilius Pharma sp.z.o.o.

    lead INDUSTRY

Principal Investigators

  • Marlene Fonseca, MD · Blueclinical, Ltd.

  • Uwe P Tigör, MD · Auxilius Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-02-08
Completion
2024-02-10

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249581 on ClinicalTrials.gov