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

Phase 1

Completed

• Conditions: Hyperlipidemias; Hypertension
• Interventions: Drug: AD-2071 10/20mg; Drug: AD-2072 80/5mg; Drug: AD-2071 10/20mg + AD2072 80/5mg

• Registration Number: NCT03632668
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2071 and AD-2072 in healthy male volunteers.

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Study Start: 2018-09-28
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequence 1	AD-2071 10/20mg	Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
Sequence 1	AD-2071 10/20mg + AD2072 80/5mg	Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD
Sequence 1	AD-2072 80/5mg	Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration	pre-dose to 24 hours	Cmax of the total ingredient of AD-2071 and AD-2072
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCtau of the total ingredient of AD-2071 and AD-20172

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax	pre-dose to 24 hours	Tmax of the total ingredient of AD-2071 and AD-2072
Elimination half-life	pre-dose to 24 hours	t1/2 of the total ingredient of AD-2071 and AD-2072
Number of participants with adverse events	From Day 1 up to Day 46	Incidence rate of adverse events
Clearance	pre-dose to 24 hours	CL/F of the total ingredient of AD-2071 and AD-2072
Volume of distribution	pre-dose to 24 hours	Vd/F of the total ingredient of AD-2071 and AD-2072

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of