Trial | NCT03586037  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
Study Started
Jun 12
2018
Primary Completion
Aug 09
2018
Study Completion
Aug 20
2018
Last Update
Oct 09
2018

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, ad-2012]

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 4 Experimental

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Sequence 5 Experimental

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD

Sequence 6 Experimental

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Sequence 1 Experimental

Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Sequence 2 Experimental

Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD

Sequence 3 Experimental

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Criteria 

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
No Results Posted