NCT03586037

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2018

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

May 28, 2018

Last Update Submit

October 8, 2018

Conditions

HyperlipidemiasHypertension

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration

    Cmax of the total ingredient of AD-2011 and AD-2012

    pre-dose to 24 hours

  • Area under the plasma concentration versus time curve

    AUCtau of the total ingredient of AD-2011 and AD-2012

    pre-dose to 24 hours

Secondary Outcomes (6)

  • Time to reach Cmax

    pre-dose to 24 hours

  • Concentration

    pre-dose to 24 hours

  • Elimination half-life

    pre-dose to 24 hours

  • Clearance

    pre-dose to 24 hours

  • Volume of distribution

    pre-dose to 24 hours

  • +1 more secondary outcomes

Study Arms (6)

Sequence 1

EXPERIMENTAL

Period 1: AD-2011 10/20mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Sequence 2

EXPERIMENTAL

Period 1: AD-2011 10/20mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2012 80mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Sequence 3

EXPERIMENTAL

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg + AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Sequence 4

EXPERIMENTAL

Period 1: AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2011 10/20mg + AD-2012 80mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Sequence 5

EXPERIMENTAL

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2011 10/20mg QD Period 3: AD-2012 80mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Sequence 6

EXPERIMENTAL

Period 1: AD-2011 10/20mg + AD-2012 80mg QD Period 2: AD-2012 80mg QD Period 3: AD-2011 10/20mg QD

Drug: AD-2011 10/20 mgDrug: AD-2012 80mgDrug: AD-2011 10/20 mg + AD-2012 80mg

Interventions

AD-2011 10/20 mgDRUG

AD-2011 10/20 mg tablet

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
AD-2012 80mgDRUG

AD-2012 80mg tablet

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
AD-2011 10/20 mg + AD-2012 80mgDRUG

AD-2011 10/20 mg + AD-2012 80mg tablet

Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Huh KY, Lee SW, Lee SB, Kim KT, Jang IJ, Lee S. Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan. Clin Pharmacol Drug Dev. 2021 Nov;10(11):1290-1296. doi: 10.1002/cpdd.926. Epub 2021 Mar 1.

    PMID: 33647189DERIVED

MeSH Terms

Conditions

HyperlipidemiasHypertension

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • In-Jin Jang, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

July 13, 2018

Study Start

June 12, 2018

Primary Completion

August 9, 2018

Study Completion

August 20, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)