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

NCT ID: NCT04600284

Last Updated: 2021-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2021-04-30

Brief Summary

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

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Detailed Description

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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Sequence 2

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Sequence 3

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Sequence 4

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Sequence 5

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Sequence 6

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

Group Type EXPERIMENTAL

AD-2101

Intervention Type DRUG

AD-2101 16/5mg

AD-2102

Intervention Type DRUG

AD-2102 25mg

AD-2101 + AD-2102

Intervention Type DRUG

AD-2101 16/5mg + AD-2102 25mg

Interventions

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AD-2101

AD-2101 16/5mg

Intervention Type DRUG

AD-2102

AD-2102 25mg

Intervention Type DRUG

AD-2101 + AD-2102

AD-2101 16/5mg + AD-2102 25mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HyeWon Chung

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-210DDI

Identifier Type: -

Identifier Source: org_study_id

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