To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
ENERGI-F705 tablets administered orally under fasting conditions.
ENERGI-F705 tablets administered orally under fasting conditions.
Matched vehicle control tablets administered orally under fasting conditions.
Taipei Medical University Hospital
Taipei, Taiwan
Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs)
Number and percentage of subjects with treatment-emergent adverse events (TEAEs).
Time frame: From dosing through end of study (approximately 4 days post-dose)
Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Cmax is defined as the highest observed whole blood concentration within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL.
Time frame: From pre-dose to 72 hours post-dose
Time to Maximum Observed Whole Blood Concentration (Tmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Tmax is defined as the time point at which Cmax is observed within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in hours.
Time frame: From pre-dose to 72 hours post-dose
Trough Whole Blood Concentration (Ctrough) of ENERGI-F705 and Its Metabolite at 72 Hours Following Single Oral Administration
Ctrough is defined as the whole blood concentration measured at 72 hours post-dose. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL.
Time frame: From pre-dose to 72 hours post-dose
Area Under the Whole Blood Concentration-Time Curve (AUC) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
AUC0-t is defined as the area under the concentration-time curve from time zero to the last measurable concentration time point. AUC0-∞ is defined as the area under the concentration-time curve from time zero to infinity. Both values will be reported separately for ENERGI-F705 and its metabolite in ng·h/mL.
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Time frame: From pre-dose to 72 hours post-dose
Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
T½ is defined as the terminal half-life, calculated as ln(2) / K\_el ≈ 0.693 / K\_el. Values will be reported separately for ENERGI-F705 and its metabolite in hours.
Time frame: From pre-dose to 72 hours post-dose
Apparent Total Body Clearance (CL/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
CL/F is defined as the apparent total body clearance, calculated as Dose / AUC0-∞. Values will be reported separately for ENERGI-F705 and its metabolite in L/h.
Time frame: From pre-dose to 72 hours post-dose
Apparent Volume of Distribution (Vd/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration
Vd/F is defined as the apparent volume of distribution, calculated as Dose / (K\_el × AUC0-∞). Values will be reported separately for ENERGI-F705 and its metabolite in liters (L).
Time frame: From pre-dose to 72 hours post-dose
Whole Blood Adenosine Triphosphate (ATP) Level Following Single Oral Administration of ENERGI-F705 Tablets
ATP levels will be measured in whole blood at each scheduled time point within the 72-hour sampling period.
Time frame: From pre-dose to 72 hours post-dose