Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

October 12, 2016 updated by: Daewon Pharmaceutical Co., Ltd.
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 1

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 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male who are ≥19, <50 years old
  • Man who weights over 55kg and whose BMI is 18~30(kg/m2)
  • Man who doesn't have any chronic disease or history of disease

Exclusion Criteria:

  • man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry

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: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reference1
single(Reference1) -> combination(Reference1+Reference2)
Drug: Rosuvastatin
Drug: Telmisartan
Drug: Amlodipine
EXPERIMENTAL: Reference2
single(Reference2) -> combination(Reference1+Reference2)
Drug: Rosuvastatin
Drug: Telmisartan
Drug: Amlodipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of Reference 1
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 1
Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 2
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 2
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour

Collaborators and Investigators

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

Sponsor

Daewon Pharmaceutical Co., Ltd.

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

November 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (ESTIMATE)

October 14, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW-1501-P101

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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