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

NCT04262765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Ramipril, Amlodipine and Atorvastatin

compare the pharmacokinetic of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose

Sponsors & Collaborators

  • Midas Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Mohammed Bader · International Pharmaceutical Research Center, Jordan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-23
Primary Completion
2019-03-26
Completion
2019-03-26

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262765 on ClinicalTrials.gov