A study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Maximum Observed Plasma Concentration (Cmax)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Area Under the Curve From Time Zero to 24 hours (AUC0-24)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Percentage of Area Under the Curve Extrapolated to Infinity (%AUCextra)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Plasma Decay Half-Life (t1/2)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Apparent Terminal Elimination Rate Constant (λz)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Apparent Total clearance, Calculated as Dose/AUCinf (CL/F)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Apparent Volume of Distribution at Terminal Phase (Vz/F)
Timeframe: Predose, 0.5, 1, 2, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48, 168, and 312 hours post dose
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Timeframe: Baseline through Day 14
Number of Participants With Change From Baseline in Laboratory Tests Results
Timeframe: Baseline through Day 14
Number of Participants With Clinically Significant Change in Vital Signs
Timeframe: Baseline through Day 14
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Abnormalities
Timeframe: Baseline through Day 14
Number of Participants With Abnormalities in Physical Examinations
Timeframe: Baseline through Day 14