Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012

Phase 1

Completed

• Conditions: Hypertension; Hyperlipidemias
• Interventions: Drug: AD-2011 10/20 mg; Drug: AD-2012 80mg; Drug: AD-2011 10/20 mg + AD-2012 80mg

• Registration Number: NCT03586037
• Lead Sponsor: Addpharma Inc.

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in healthy male volunteers.

Detailed Description

To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the single administration of AD-2011 and AD-2012.

Study Timeline

• Study First Submitted: 2018-05-28
• Study Start: 2018-06-12
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Primary Completion: 2018-08-09
• Study Completion: 2018-08-20
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

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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
• AST, ALT values over than 1.5 times of ULN at screening
• HDL values less than 35 mg/dL
• A person who has a history of drug abuse or who has positive result for an abuse drug in a urine screening test

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD
Sequence 3	AD-2011 10/20 mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Sequence 1	AD-2011 10/20 mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 1	AD-2012 80mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 1	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 2	AD-2011 10/20 mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD
Sequence 2	AD-2012 80mg	Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD
Sequence 3	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Sequence 4	AD-2012 80mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 4	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 6	AD-2011 10/20 mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Sequence 3	AD-2012 80mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Sequence 4	AD-2011 10/20 mg	Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD
Sequence 5	AD-2011 10/20 mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD
Sequence 5	AD-2012 80mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD
Sequence 5	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD
Sequence 6	AD-2011 10/20 mg + AD-2012 80mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD
Sequence 6	AD-2012 80mg	Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve	pre-dose to 24 hours	AUCtau of the total ingredient of AD-2011 and AD-2012
Peak Plasma Concentration	pre-dose to 24 hours	Cmax of the total ingredient of AD-2011 and AD-2012

Secondary Outcome Measures

Name	Time	Method
Elimination half-life	pre-dose to 24 hours	t1/2 of the total ingredient of AD-2011 and AD-2012
Time to reach Cmax	pre-dose to 24 hours	Tmax of the total ingredient of AD-2011 and AD-2012
Concentration	pre-dose to 24 hours	Ctrough of the total ingredient of AD-2011 and AD-2012
Volume of distribution	pre-dose to 24 hours	Vd/F of the total ingredient of AD-2011 and AD-2012
Clearance	pre-dose to 24 hours	CL/F of the total ingredient of AD-2011 and AD-2012
Number of participants with adverse events	From Day 1 up to Day 45	Incidence rate of adverse events

Trial Locations

Locations (1)

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