Evaluating a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin

May 15, 2014 updated by: Hanmi Pharmaceutical Company Limited

An Open-label, Randomized, Single-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Amlodipine/Losartan and Rosuvastatin in Healthy Male Volunteers

The purpose of this study is to evaluate the drug-drug interaction between amlodipine/losartan and rosuvastatin in healthy male volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samgsung Seoul Hospital
        • Principal Investigator:
          • JaeWook Ko, M.D.

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

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male
  • Age between 19 and 55
  • Signed informed consent

Exclusion Criteria:

  • Presence of medical history or a concurrent disease
  • Has a history of hypersensitivity to IP ingredients

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
amosartan → rosuvastatin → amosartan and rosuvastatin
Drug: rosuvastatin
Other Names:
  • rosuvastatin, P.O
Drug: amosartan
Other Names:
  • amosartan, P.O
Drug: amosartan and rosuvastatin
Other Names:
  • amosartan and rosuvastatin, P.O
Experimental: Sequence 2
rosuvastatin → amosartan and rosuvastatin → amosartan
Drug: rosuvastatin
Other Names:
  • rosuvastatin, P.O
Drug: amosartan
Other Names:
  • amosartan, P.O
Drug: amosartan and rosuvastatin
Other Names:
  • amosartan and rosuvastatin, P.O
Experimental: Sequence 3
amosartan and rosuvastatin → amosartan → rosuvastatin
Drug: rosuvastatin
Other Names:
  • rosuvastatin, P.O
Drug: amosartan
Other Names:
  • amosartan, P.O
Drug: amosartan and rosuvastatin
Other Names:
  • amosartan and rosuvastatin, P.O

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax
Time Frame: 0-72h
0-72h
AUClast
Time Frame: 0-72h
0-72h

Secondary Outcome Measures

Outcome Measure
Time Frame
tmax
Time Frame: 0-72h
0-72h
t1/2
Time Frame: 0-72h
0-72h
AUCinf
Time Frame: 0-72h
0-72h

Collaborators and Investigators

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

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: JaeWook Ko, M.D., Samsung Seoul Hospital

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

February 1, 2014

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

March 9, 2014

First Submitted That Met QC Criteria

May 15, 2014

First Posted (Estimate)

May 16, 2014

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ALRO-101

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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