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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Hypertension; Hyperlipidemias

Treatments: Drug: AD-2071 10/20mg; Drug: AD-2072 80/5mg; Drug: AD-2071 10/20mg + AD2072 80/5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03632668

AD-207DDI

Details and patient eligibility

About

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

Full description

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

Enrollment: 38 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Sequence 1

Experimental group

Description:

Period 1: AD-2071 10/20mg QD Period 2: AD-2072 80/5mg QD and AD-2071 10/20mg + AD-2072 80/5mg QD

Treatment:

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

Drug: AD-2072 80/5mg

Drug: AD-2071 10/20mg