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

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: AD-2101; Drug: AD-2102; Drug: AD-2101 + AD-2102

• Registration Number: NCT04600284
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2020-11-16
• Primary Completion: 2021-01-20
• Study Completion: 2021-04-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	AD-2102	Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Sequence 4	AD-2101 + AD-2102	Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Sequence 5	AD-2101	Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Sequence 3	AD-2102	Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Sequence 5	AD-2101 + AD-2102	Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Sequence 1	AD-2101 + AD-2102	Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Sequence 2	AD-2101 + AD-2102	Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Sequence 3	AD-2101	Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Sequence 3	AD-2101 + AD-2102	Period 1: AD-2102 Period 2: AD-2101 Period 3: AD-2101 + AD-2102
Sequence 4	AD-2101	Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Sequence 6	AD-2102	Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
Sequence 1	AD-2101	Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Sequence 6	AD-2101	Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101
Sequence 5	AD-2102	Period 1: AD-2101 + AD-2102 Period 2: AD-2101 Period 3: AD-2102
Sequence 1	AD-2102	Period 1: AD-2101 Period 2: AD-2102 Period 3: AD-2101 + AD-2102
Sequence 2	AD-2101	Period 1: AD-2101 Period 2: AD-2101 + AD-2102 Period 3: AD-2102
Sequence 4	AD-2102	Period 1: AD-2102 Period 2: AD-2101 + AD-2102 Period 3: AD-2101
Sequence 6	AD-2101 + AD-2102	Period 1: AD-2101 + AD-2102 Period 2: AD-2102 Period 3: AD-2101

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration	pre-dose to 24 hours	Cmax,ss of the total ingredient of AD-2101 and AD-2102
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCt,ss of the total ingredient of AD-2101 and AD-2102

Secondary Outcome Measures

Name	Time	Method
Bottom Plasma Concentration	pre-dose to 24 hours	Cmin,ss of the total ingredient of AD-2101 and AD-2102
Number of participants with adverse events	From Day 1 up to Day 66	Incidence rate of adverse events
Clearance	pre-dose to 24 hours	CLss/F of the total ingredient of AD-2101 and AD-2102
Time to reach Cmax	pre-dose to 24 hours	Tmax,ss of the total ingredient of AD-2101 and AD-2102

Trial Locations

Locations (1)

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