Pharmacokinetics, Smoking Cessation
Conditions
Brief summary
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
Interventions
DRUGCDFF0318, Champix
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
Sponsors
CTC Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects aged 19 to 45 years * a body mass index of 18.0-30.0 kg/m2
Exclusion criteria
* Subjects with disease history or current disease of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood/tumor, urinary system, cardiovascular system, etc. * Subjects with a history of gastrointestinal diseases or gastrointestinal surgery that may affect the absorption of investigational drugs * Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing varenicline and other drugs (ketoprofen, aspirin, antibiotics, etc.) * Subjects who have an abnormal diet that may affect the absorption, distribution, metabolism, and excretion of the drug, or who eat food that may affect drug metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (AUC0-t) | 72 hours | AUC0-t of CDFF0318 and Champix Tab. 1mg |
| Pharmacokinetics (Cmax) | 72 hours | Cmax of CDFF0318 and Champix Tab. 1mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability (Vital sign) | 72 hours | Blood pressure (mmHg) |
| Safety and tolerability (12-lead ECG) | 72 hours | ventricular rate (beats/min) |
| Safety and tolerability (Laboratory tests) | 72 hours | Creatinine \[mg/dL\] |
| Safety and tolerability (Adverse events) | 72 hours | Adverse events were collected regardless of the time point when the subject complained of symptoms. Adverse events were assessed by CTCAE v5.0 |
Countries
South Korea
Outcome results
None listed