- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586037
Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012
October 8, 2018 updated by: Addpharma Inc.
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
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
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
|
AD-2011 10/20 mg tablet
AD-2012 80mg tablet
AD-2011 10/20 mg + AD-2012 80mg tablet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Plasma Concentration
Time Frame: pre-dose to 24 hours
|
Cmax of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
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
|
pre-dose to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to reach Cmax
Time Frame: pre-dose to 24 hours
|
Tmax of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
Concentration
Time Frame: pre-dose to 24 hours
|
Ctrough of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
Elimination half-life
Time Frame: pre-dose to 24 hours
|
t1/2 of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
Clearance
Time Frame: pre-dose to 24 hours
|
CL/F of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
Volume of distribution
Time Frame: pre-dose to 24 hours
|
Vd/F of the total ingredient of AD-2011 and AD-2012
|
pre-dose to 24 hours
|
Number of participants with adverse events
Time Frame: From Day 1 up to Day 45
|
Incidence rate of adverse events
|
From Day 1 up to Day 45
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: In-Jin Jang, M.D., Ph.D, Seoul National University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 12, 2018
Primary Completion (Actual)
August 9, 2018
Study Completion (Actual)
August 20, 2018
Study Registration Dates
First Submitted
May 28, 2018
First Submitted That Met QC Criteria
July 2, 2018
First Posted (Actual)
July 13, 2018
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 8, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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