A Phase 1 Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics after Administration of the "CDFF0318" and "Champix Tab. 1mg (Varenicline tartrate)" in Healthy Male Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
Chungbuk National University Hospital
Cheongju-si, South Korea
Pharmacokinetics (AUC0-t)
AUC0-t of "CDFF0318" and "Champix Tab. 1mg"
Time frame: 72 hours
Pharmacokinetics (Cmax)
Cmax of "CDFF0318" and "Champix Tab. 1mg"
Time frame: 72 hours
Safety and tolerability (Vital sign)
Blood pressure (mmHg)
Time frame: 72 hours
Safety and tolerability (Vital sign)
Heart rate (beats/min)
Time frame: 72 hours
Safety and tolerability (12-lead ECG)
ventricular rate (beats/min)
Time frame: 72 hours
Safety and tolerability (12-lead ECG)
PR interval (msec)
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
Creatinine \[mg/dL\]
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
AST, ALT \[IU/L\]
Time frame: 72 hours
Safety and tolerability (Laboratory tests)
eGFR \[mL/min/1.73m\^2\]
Time frame: 72 hours
Safety and tolerability (Adverse events)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Adverse events were collected regardless of the time point when the subject complained of symptoms. Adverse events were assessed by CTCAE v5.0
Time frame: 72 hours