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NCT04600284 Clinical Trial

Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102

Hypertension Clinical Trial

Official title:
A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04600284
Other study ID # AD-210DDI
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 16, 2020
Est. completion date April 30, 2021

Study information
Verified date July 2021
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Description:

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date April 30, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-2101
AD-2101 16/5mg
• AD-2102
AD-2102 25mg
• AD-2101 + AD-2102
AD-2101 16/5mg + AD-2102 25mg

Locations
Country Name City State
Korea, Republic of Korea University Guro Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration Cmax,ss of the total ingredient of AD-2101 and AD-2102 pre-dose to 24 hours
Primary 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 Time to reach Cmax Tmax,ss of the total ingredient of AD-2101 and AD-2102 pre-dose to 24 hours
Secondary Clearance CLss/F of the total ingredient of AD-2101 and AD-2102 pre-dose to 24 hours
Secondary Bottom Plasma Concentration Cmin,ss of the total ingredient of AD-2101 and AD-2102 pre-dose to 24 hours
Secondary Number of participants with adverse events Incidence rate of adverse events From Day 1 up to Day 66
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