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

A

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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