Smoking Cessation Clinical Trial
Official title:
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
Verified date | October 2020 |
Source | CTC Bio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 32 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 19 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Chungbuk National University Hospital | Cheongju-si |
Lead Sponsor | Collaborator |
---|---|
CTC Bio, Inc. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetics (AUC0-t) | AUC0-t of "CDFF0318" and "Champix Tab. 1mg" | 72 hours | |
Primary | Pharmacokinetics (Cmax) | Cmax of "CDFF0318" and "Champix Tab. 1mg" | 72 hours | |
Secondary | Safety and tolerability (Vital sign) | Blood pressure (mmHg) | 72 hours | |
Secondary | Safety and tolerability (Vital sign) | Heart rate (beats/min) | 72 hours | |
Secondary | Safety and tolerability (12-lead ECG) | ventricular rate (beats/min) | 72 hours | |
Secondary | Safety and tolerability (12-lead ECG) | PR interval (msec) | 72 hours | |
Secondary | Safety and tolerability (Laboratory tests) | Creatinine [mg/dL] | 72 hours | |
Secondary | Safety and tolerability (Laboratory tests) | AST, ALT [IU/L] | 72 hours | |
Secondary | Safety and tolerability (Laboratory tests) | eGFR [mL/min/1.73m^2] | 72 hours | |
Secondary | Safety and tolerability (Adverse events) | Adverse events were collected regardless of the time point when the subject complained of symptoms.
Adverse events were assessed by CTCAE v5.0 |
72 hours |
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