NCT04631874CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- CTC Bio, Inc.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (AUC0-t)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
Sequence A(RT)
Experimental
Reference drug (Champix) -> washout -> test drug (CDFF0318)
Intervention: CDFF0318, Champix (Drug)
Sequence B(TR)
Experimental
Test drug (CDFF0318) -> washout -> reference drug (Champix)
Intervention: CDFF0318, Champix (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (AUC0-t)
Time Frame: 72 hours
AUC0-t of "CDFF0318" and "Champix Tab. 1mg"
Pharmacokinetics (Cmax)
Time Frame: 72 hours
Cmax of "CDFF0318" and "Champix Tab. 1mg"
Secondary Outcomes
- Safety and tolerability (Adverse events)(72 hours)
- Safety and tolerability (Vital sign)(72 hours)
- Safety and tolerability (Laboratory tests)(72 hours)
- Safety and tolerability (12-lead ECG)(72 hours)
Investigators
Study Sites (1)
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