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

Primary Purpose

Hyperlipidemias, Hypertension

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-2011 10/20 mg
AD-2012 80mg
AD-2011 10/20 mg + AD-2012 80mg
Sponsored by
Addpharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Peak Plasma Concentration
Cmax of the total ingredient of AD-2011 and AD-2012
Area under the plasma concentration versus time curve
AUCtau of the total ingredient of AD-2011 and AD-2012

Secondary Outcome Measures

Time to reach Cmax
Tmax of the total ingredient of AD-2011 and AD-2012
Concentration
Ctrough of the total ingredient of AD-2011 and AD-2012
Elimination half-life
t1/2 of the total ingredient of AD-2011 and AD-2012
Clearance
CL/F of the total ingredient of AD-2011 and AD-2012
Volume of distribution
Vd/F of the total ingredient of AD-2011 and AD-2012
Number of participants with adverse events
Incidence rate of adverse events

Full Information

First Posted
May 28, 2018
Last Updated
October 8, 2018
Sponsor
Addpharma Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03586037
Brief Title
Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012
Official Title
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
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
August 9, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
Detailed Description
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Intervention Type
Drug
Intervention Name(s)
AD-2011 10/20 mg
Intervention Description
AD-2011 10/20 mg tablet
Intervention Type
Drug
Intervention Name(s)
AD-2012 80mg
Intervention Description
AD-2012 80mg tablet
Intervention Type
Drug
Intervention Name(s)
AD-2011 10/20 mg + AD-2012 80mg
Intervention Description
AD-2011 10/20 mg + AD-2012 80mg tablet
Primary Outcome Measure Information:
Title
Peak Plasma Concentration
Description
Cmax of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Area under the plasma concentration versus time curve
Description
AUCtau of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Secondary Outcome Measure Information:
Title
Time to reach Cmax
Description
Tmax of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Concentration
Description
Ctrough of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Elimination half-life
Description
t1/2 of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Clearance
Description
CL/F of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Volume of distribution
Description
Vd/F of the total ingredient of AD-2011 and AD-2012
Time Frame
pre-dose to 24 hours
Title
Number of participants with adverse events
Description
Incidence rate of adverse events
Time Frame
From Day 1 up to Day 45

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, M.D., Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33647189
Citation
Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1.
Results Reference
derived

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

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