Clinical Trials Logo
  1. Home
  2. Hypertension
  3. NCT03586037
  4. Details
NCT03586037 Clinical Trial

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

Hypertension Clinical Trial

Official title:
An Open-label, Sequence-randomized, Three-period, Six-sequence, Multiple Dosing Crossover Clinical Trial to Evaluate the Pharmacokinetic Interaction Between AD-2011 and AD-2012 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03586037
Other study ID # AD-201
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 12, 2018
Est. completion date August 20, 2018

Study information
Verified date October 2018
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 20, 2018
Est. primary completion date August 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 50 Years
Eligibility 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

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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration Cmax of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Primary 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 Time to reach Cmax Tmax of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Secondary Concentration Ctrough of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Secondary Elimination half-life t1/2 of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Secondary Clearance CL/F of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Secondary Volume of distribution Vd/F of the total ingredient of AD-2011 and AD-2012 pre-dose to 24 hours
Secondary Number of participants with adverse events Incidence rate of adverse events From Day 1 up to Day 45
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A