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Clinical Trial to Compare the Pharmacokinetics of DP-R208

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707224
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : March 23, 2016
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

Brief Summary:
A randomized, single-dose, open, crossover clinical trial to compare the pharmacokinetics of DP-R208 (Candesartan cilexetil and Rosuvastatin calcium fixed dose combinations) in comparison to each component administered alone in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: DP-R208 Drug: Candesartan cilexetil Drug: Rosuvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Single-dose, Open, Crossover Clinical Trial to Compare the Pharmacokinetics of DP-R208 (Candesartan Cilexetil and Rosuvastatin Calcium Fixed Dose Combinations) in Comparison to Each Component Administered Alone in Healthy Male Volunteers
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
combination dose of Candesartan cilexetil 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: Group B
DP-R208 and combination dose of Candesartan cilexetil 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




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: up to 72 hours post dose ]
  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 72 hours post dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 17.5~30.5
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707224


Sponsors and Collaborators
Alvogen Korea
Investigators
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Principal Investigator: Min-Gul Kim, Ph.D Chonbuk National University Hospital

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Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02707224    
Other Study ID Numbers: DP-CTR208-I-02
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 23, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alvogen Korea:
DP-R208
Additional relevant MeSH terms:
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Candesartan
Candesartan cilexetil
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists