NCT04631874

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
Last Updated

November 17, 2020

Status Verified

October 1, 2020

Enrollment Period

9 months

First QC Date

October 27, 2020

Last Update Submit

November 15, 2020

Conditions

Smoking CessationPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (AUC0-t)

    AUC0-t of "CDFF0318" and "Champix Tab. 1mg"

    72 hours

  • Pharmacokinetics (Cmax)

    Cmax of "CDFF0318" and "Champix Tab. 1mg"

    72 hours

Secondary Outcomes (8)

  • Safety and tolerability (Vital sign)

    72 hours

  • Safety and tolerability (Vital sign)

    72 hours

  • Safety and tolerability (12-lead ECG)

    72 hours

  • Safety and tolerability (12-lead ECG)

    72 hours

  • Safety and tolerability (Laboratory tests)

    72 hours

  • +3 more secondary outcomes

Study Arms (2)

Sequence A(RT)

EXPERIMENTAL

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

Drug: CDFF0318, Champix

Sequence B(TR)

EXPERIMENTAL

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

Drug: CDFF0318, Champix

Interventions

CDFF0318, ChampixDRUG

CDFF0318: Varenicline salt changed Champix: Varenicline tartrate

Sequence A(RT)Sequence B(TR)

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects aged 19 to 45 years
  • a body mass index of 18.0-30.0 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinoxalines

Study Officials

  • Min-Kyu Park

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 17, 2020

Study Start

July 24, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 17, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)