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Clinical Trials/NCT04631874
NCT04631874
Completed
Phase 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

CTC Bio, Inc.1 site in 1 country32 target enrollmentJuly 24, 2019
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ConditionsSmoking CessationPharmacokinetics
InterventionsCDFF0318, Champix
DrugsCDFF0318, Champix

Overview

Phase
Phase 1
Intervention
CDFF0318, Champix
Conditions
Smoking Cessation
Sponsor
CTC Bio, Inc.
Enrollment
32
Locations
1
Primary Endpoint
Pharmacokinetics (AUC0-t)
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

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

Registry
clinicaltrials.gov
Start Date
July 24, 2019
End Date
May 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility 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

Arms & Interventions

Sequence A(RT)

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

Intervention: CDFF0318, Champix

Sequence B(TR)

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

Intervention: CDFF0318, Champix

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)

Study Sites (1)

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