Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102
A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 hypertension
Started Nov 2020
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
October 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
November 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedJuly 21, 2021
July 1, 2021
2 months
October 19, 2020
July 20, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Peak Plasma Concentration
Cmax,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Area under the plasma concentration versus time curve
AUCt,ss of the total ingredient of AD-2101 and AD-2102
pre-dose to 24 hours
Secondary Outcomes (4)
Time to reach Cmax
pre-dose to 24 hours
Clearance
pre-dose to 24 hours
Bottom Plasma Concentration
pre-dose to 24 hours
Number of participants with adverse events
From Day 1 up to Day 66
Study Arms (6)
Sequence 1
EXPERIMENTALPeriod 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Sequence 2
EXPERIMENTALPeriod 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Sequence 3
EXPERIMENTALPeriod 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Sequence 4
EXPERIMENTALPeriod 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Sequence 5
EXPERIMENTALPeriod 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Sequence 6
EXPERIMENTALPeriod 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
Interventions
AD-2101 16/5mg + AD-2102 25mg
Eligibility Criteria
You may qualify if:
- Healthy male between 19 and 50 years of age at the time of screening
- Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2
You may not qualify if:
- Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
- Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
- A person who has a history of drug abuse
- AST, ALT, Total bilirubin values over than 2 times of UNL at screening
- Creatinine clearance under 80mL/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Addpharma Inc.lead
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
HyeWon Chung
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
November 16, 2020
Primary Completion
January 20, 2021
Study Completion
April 30, 2021
Last Updated
July 21, 2021
Record last verified: 2021-07