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

Addpharma

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: AD-2101; Drug: AD-2101 + AD-2102; Drug: AD-2102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04600284

AD-210DDI

Details and patient eligibility

About

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

Full description

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

Enrollment: 25 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102

Sequence 2

Experimental group

Description:

Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102

Sequence 3

Experimental group

Description:

Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102

Sequence 4

Experimental group

Description:

Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102

Sequence 5

Experimental group

Description:

Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102

Sequence 6

Experimental group

Description:

Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101

Treatment:

Drug: AD-2101

Drug: AD-2101 + AD-2102

Drug: AD-2102