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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631874
Recruitment Status : Completed
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
CTC Bio, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Smoking Cessation Pharmacokinetics Drug: CDFF0318, Champix Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 24, 2019
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequence A(RT)
Reference drug (Champix) -> washout -> test drug (CDFF0318)
 Drug: CDFF0318, Champix
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
Experimental: Sequence B(TR)
Test drug (CDFF0318) -> washout -> reference drug (Champix)
 Drug: CDFF0318, Champix
CDFF0318: Varenicline salt changed Champix: Varenicline tartrate


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (AUC0-t) [ Time Frame: 72 hours ]
    AUC0-t of "CDFF0318" and "Champix Tab. 1mg"

  2. Pharmacokinetics (Cmax) [ Time Frame: 72 hours ]
    Cmax of "CDFF0318" and "Champix Tab. 1mg"


Secondary Outcome Measures :
  1. Safety and tolerability (Vital sign) [ Time Frame: 72 hours ]
    Blood pressure (mmHg)

  2. Safety and tolerability (Vital sign) [ Time Frame: 72 hours ]
    Heart rate (beats/min)

  3. Safety and tolerability (12-lead ECG) [ Time Frame: 72 hours ]
    ventricular rate (beats/min)

  4. Safety and tolerability (12-lead ECG) [ Time Frame: 72 hours ]
    PR interval (msec)

  5. Safety and tolerability (Laboratory tests) [ Time Frame: 72 hours ]
    Creatinine [mg/dL]

  6. Safety and tolerability (Laboratory tests) [ Time Frame: 72 hours ]
    AST, ALT [IU/L]

  7. Safety and tolerability (Laboratory tests) [ Time Frame: 72 hours ]
    eGFR [mL/min/1.73m^2]

  8. Safety and tolerability (Adverse events) [ Time Frame: 72 hours ]

    Adverse events were collected regardless of the time point when the subject complained of symptoms.

    Adverse events were assessed by CTCAE v5.0



Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631874


Locations
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Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Korea, Republic of
Sponsors and Collaborators
CTC Bio, Inc.
Investigators
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Principal Investigator: Min-Kyu Park Chungbuk National University Hospital
More Information
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Responsible Party: CTC Bio, Inc.
ClinicalTrials.gov Identifier: NCT04631874    
Other Study ID Numbers: CTC-IND-CDFF0318_1
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs