Drug-drug-interaction Study of Ramipril, Amlodipine and Atorvastatin

February 7, 2020 updated by: Midas Pharma GmbH

Open Label, Comparative, Multiple-dose, Fixed-sequence Steady State Trial in Healthy Volunteers to Assess the Pharmacokinetic Interaction of Ramipril, Atorvastatin and Amlodipine After a Multiple Oral Dose Administration

Study to determine the potential pharmacokinetic interaction of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate and amlodipine as amlodipine besilate at steady state after a multiple oral administration and to monitor the safety of the co-administration of these drugs. This study aims to determine if the steady state study pharmacokinetic parameters of any of the given drugs and the tolerability is altered when administered concomitantly.

Study Overview

Status

Completed

Conditions

Detailed Description

This study was an open-label, comparative, multiple-dose, fixed sequence steady state trial to compare the pharmacokinetic of ramipril, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate given as a multiple dose under fasting conditions in the absence and presence of each other.

Bioanalysis of ramipril, ramiprilat, atorvastatin and amlodipine is performed by LC/MS/MS method.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amman, Jordan
        • International Pharmaceutical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male Caucasian, aged 18 to 50 years, inclusive.
  • Body Mass Index (BMI) range within 18.5 - 30.0 Kg/m2.
  • Physically and mentally healthy as judged by means of medical and standard laboratory examinations. Medical demographics performed not longer than two weeks before the initiation of the clinical study with significant deviations from the normal ranges.
  • Standard ECG assessment is normal
  • Informed consent given in written form according to chapter 5.3 of the study protocol.

Exclusion Criteria:

  • Known allergy to the drugs under investigation or any ingredients or any other related drugs.
  • Participation in a relative bioavailability study or in a clinical study within the last 80 days before first study drug administration or blood donation
  • Presence of any clinically significant results from laboratory tests, vital sign assessment and electrocardiogram as judged by the investigator. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
  • Results of CPK or liver or kidney function tests which are outside the reference range.
  • Hb test lower than 13.3 g/dl.
  • Positive serologic findings
  • History of drug or alcohol abuse.
  • Subject is a heavy smoker.
  • Subject has a history of significant asthma, peptic or gastric ulcer, sinusitis, pharyngitis, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, dermatologic or immunological disorders.
  • Subject having at screening examination a sitting blood pressure of less than 110/70 mm Hg or more than or equal to 140/90 mm Hg.
  • Subjects who are known or suspected: not to comply with the study directives, not to be reliable or trustworthy, not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed, to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A-B-C-ABC

The demographic characteristics of the 18 male subjects were as follows:

  • Age: 18-49 years
  • Weight: 55-105 kg
  • Height: 163-188 cm
  • BMI 18.5-29.9 kg/m²
compare the pharmacokinetic of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the Plasma concentration curve (AUC0-t)
Time Frame: up to 24 hours post-administration at steady state
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
up to 24 hours post-administration at steady state
Maximum Plasma Concentration at steady state
Time Frame: up to 24 hours post-administration at steady state
Maximum plasma concentration, it is read directly from the raw data
up to 24 hours post-administration at steady state

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measurement (Adverse Events)
Time Frame: complete study, Day 1 until Day 31 (Follow-up)
All observed or volunteered safety events regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported during study.
complete study, Day 1 until Day 31 (Follow-up)
Time until Cmaxss is reached (tmaxss)
Time Frame: up to 24 hours post-administration at steady state
Time until Cmax is reached, it is read directly from the observed concentrations
up to 24 hours post-administration at steady state

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mohammed Bader, International Pharmaceutical Research Center, Jordan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2019

Primary Completion (Actual)

March 26, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 10, 2020

Last Update Submitted That Met QC Criteria

February 7, 2020

Last Verified

February 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Ramipril, Amlodipine and Atorvastatin

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