Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072
An Open-label, Two-period, One-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in Healthy Male Volunteers
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2019
CompletedJuly 5, 2019
July 1, 2019
4 months
August 13, 2018
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Peak Plasma Concentration
Cmax of the total ingredient of AD-2071 and AD-2072
pre-dose to 24 hours
Area under the plasma concentration versus time curve
AUCtau of the total ingredient of AD-2071 and AD-20172
pre-dose to 24 hours
Secondary Outcomes (5)
Time to reach Cmax
pre-dose to 24 hours
Elimination half-life
pre-dose to 24 hours
Clearance
pre-dose to 24 hours
Volume of distribution
pre-dose to 24 hours
Number of participants with adverse events
From Day 1 up to Day 46
Study Arms (1)
Sequence 1
EXPERIMENTALPeriod 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- HDL values less than 35 mg/dL
- AST, ALT values over than 1.5 times of ULN at screening
- A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jin Jang, M.D.,Ph.D
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 15, 2018
Study Start
September 28, 2018
Primary Completion
January 24, 2019
Study Completion
January 24, 2019
Last Updated
July 5, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share