A Clinical Trial to Compare Pharmacokinetics of the "CDFF0318" and "Champix Tab. 1mg"

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CTC Bio, Inc.
• Treatments: Varenicline

Criteria

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