- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04262765
Drug-drug-interaction Study of Ramipril, Amlodipine and Atorvastatin
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Amman, Jordan
- International Pharmaceutical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Experimental: Treatment A-B-C-ABC
The demographic characteristics of the 18 male subjects were as follows:
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compare the pharmacokinetic of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
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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
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Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
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up to 24 hours post-administration at steady state
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Maximum Plasma Concentration at steady state
Time Frame: up to 24 hours post-administration at steady state
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Maximum plasma concentration, it is read directly from the raw data
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up to 24 hours post-administration at steady state
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety measurement (Adverse Events)
Time Frame: complete study, Day 1 until Day 31 (Follow-up)
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All observed or volunteered safety events regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported during study.
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complete study, Day 1 until Day 31 (Follow-up)
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Time until Cmaxss is reached (tmaxss)
Time Frame: up to 24 hours post-administration at steady state
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Time until Cmax is reached, it is read directly from the observed concentrations
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up to 24 hours post-administration at steady state
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohammed Bader, International Pharmaceutical Research Center, Jordan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin-Converting Enzyme Inhibitors
- Atorvastatin
- Amlodipine
- Ramipril
- Amlodipine, atorvastatin drug combination
Other Study ID Numbers
- RAAMAT-T1018/66
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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