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NCT03632668 Clinical Trial

Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072

Hypertension Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03632668
Other study ID # AD-207DDI
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 28, 2018
Est. completion date January 24, 2019

Study information
Verified date July 2019
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-2071 and AD-2072 in healthy male volunteers.

Description:

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2071 and AD-2072.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date January 24, 2019
Est. primary completion date January 24, 2019
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 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

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-2071 10/20mg
AD-2071 10/20 mg tablet
• AD-2072 80/5mg
AD-2072 80/5mg tablet
• AD-2071 10/20mg + AD2072 80/5mg
AD-2071 10/20 mg + AD-2072 80/5mg tablet

Locations
Country Name City State
Korea, Republic of Seoul National University 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 of the total ingredient of AD-2071 and AD-2072 pre-dose to 24 hours
Primary 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 Time to reach Cmax Tmax of the total ingredient of AD-2071 and AD-2072 pre-dose to 24 hours
Secondary Elimination half-life t1/2 of the total ingredient of AD-2071 and AD-2072 pre-dose to 24 hours
Secondary Clearance CL/F of the total ingredient of AD-2071 and AD-2072 pre-dose to 24 hours
Secondary Volume of distribution Vd/F of the total ingredient of AD-2071 and AD-2072 pre-dose to 24 hours
Secondary Number of participants with adverse events Incidence rate of adverse events From Day 1 up to Day 46
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