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

NCT ID: NCT04631874

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2020-05-01

Brief Summary

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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

Detailed Description

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Conditions

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Smoking Cessation Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A(RT)

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

Group Type EXPERIMENTAL

CDFF0318, Champix

Intervention Type DRUG

CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Sequence B(TR)

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

Group Type EXPERIMENTAL

CDFF0318, Champix

Intervention Type DRUG

CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Interventions

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CDFF0318, Champix

CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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CTC Bio, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min-Kyu Park

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Locations

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Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CTC-IND-CDFF0318_1

Identifier Type: -

Identifier Source: org_study_id