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

CTCBIO

Status and phase: Completed; Phase 1

Conditions: Smoking Cessation; Pharmacokinetics

Treatments: Drug: CDFF0318, Champix

Study type: Interventional

Funder types: Industry

Identifiers

NCT04631874

CTC-IND-CDFF0318_1

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Sequence A(RT)

Experimental group

Description:

Reference drug (Champix) -\> washout -\> test drug (CDFF0318)

Treatment:

Drug: CDFF0318, Champix

Sequence B(TR)

Experimental group

Description:

Test drug (CDFF0318) -\> washout -\> reference drug (Champix)

Treatment:

Drug: CDFF0318, Champix