Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012

Overview

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.

Full Title of Study: “An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 9, 2018

Detailed Description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Interventions

  • Drug: AD-2011 10/20 mg
    • AD-2011 10/20 mg tablet
  • Drug: AD-2012 80mg
    • AD-2012 80mg tablet
  • Drug: AD-2011 10/20 mg + AD-2012 80mg
    • AD-2011 10/20 mg + AD-2012 80mg tablet

Arms, Groups and Cohorts

  • Experimental: Sequence 1
    • Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
  • Experimental: Sequence 2
    • Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD
  • Experimental: Sequence 3
    • Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
  • Experimental: Sequence 4
    • Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
  • Experimental: Sequence 5
    • Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD
  • Experimental: Sequence 6
    • Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Clinical Trial Outcome Measures

Primary Measures

  • Peak Plasma Concentration
    • Time Frame: pre-dose to 24 hours
    • Cmax of the total ingredient of AD-2011 and AD-2012
  • Area under the plasma concentration versus time curve
    • Time Frame: pre-dose to 24 hours
    • AUCtau of the total ingredient of AD-2011 and AD-2012

Secondary Measures

  • Time to reach Cmax
    • Time Frame: pre-dose to 24 hours
    • Tmax of the total ingredient of AD-2011 and AD-2012
  • Concentration
    • Time Frame: pre-dose to 24 hours
    • Ctrough of the total ingredient of AD-2011 and AD-2012
  • Elimination half-life
    • Time Frame: pre-dose to 24 hours
    • t1/2 of the total ingredient of AD-2011 and AD-2012
  • Clearance
    • Time Frame: pre-dose to 24 hours
    • CL/F of the total ingredient of AD-2011 and AD-2012
  • Volume of distribution
    • Time Frame: pre-dose to 24 hours
    • Vd/F of the total ingredient of AD-2011 and AD-2012
  • Number of participants with adverse events
    • Time Frame: From Day 1 up to Day 45
    • Incidence rate of adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy male between 19 and 50 years of age at the time of screening – Weight between 50 kg and 90 kg and body mass index (BMI) between 18.0 kg/m2 and 27.0 kg/m2 Exclusion Criteria:

  • Clinically significant disease or history of clinically significant disease such as liver, kidney, nervous system, respiratory, endocrine*hematologic, cardiovascular, urinary, psychiatric – Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery – AST, ALT values over than 1.5 times of ULN at screening – HDL values less than 35 mg/dL – A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Addpharma Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • In-Jin Jang, M.D., Ph.D, Principal Investigator, Seoul National University Hospital

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