DP-R208 Pharmacokinetic Study

June 7, 2016 updated by: Alvogen Korea

DP-R208 Pharmacokinetic Study Phase I

An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

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 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI 18~30
  • signed the informed consent form prior to the study participation

Exclusion Criteria:

  • Clinically significant disease
  • Previously donate whole blood within 60 days or component blood within 14 days
  • Clinically significant allergic disease
  • Taken IP in other trial within 90 days
  • An impossible one who participates in clinical trial by investigator's decision including laboratory test result

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RT group
combination dose of Candesartan and Rosuvastatin and DP-R208 in order
Drug: DP-R208
Investigational product is prescribed to all of randomized subjects
Drug: Candesartan cilexetil
Investigational product is prescribed to all of randomized subjects
Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects
EXPERIMENTAL: TR group
DP-R208 and combination dose of Candesartan and Rosuvastatin in order
Drug: DP-R208
Investigational product is prescribed to all of randomized subjects
Drug: Candesartan cilexetil
Investigational product is prescribed to all of randomized subjects
Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC)
Time Frame: up to 48 hours post dose
up to 48 hours post dose
Peak Plasma Concentration (Cmax)
Time Frame: up to 48 hours post dose
up to 48 hours post dose

Collaborators and Investigators

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

Sponsor

Alvogen Korea

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

March 1, 2016

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (ESTIMATE)

March 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DP-CTR208-I-04

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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