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DP-R208 Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT02709187
Recruitment Status : Completed
First Posted : March 15, 2016
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alvogen Korea

Brief Summary:
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

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 : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DP-R208 Pharmacokinetic Study Phase I
Study Start Date : March 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Candesartan

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




Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: up to 48 hours post dose ]
  2. Peak Plasma Concentration (Cmax) [ Time Frame: up to 48 hours post dose ]


Information from the National Library of Medicine

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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 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

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Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02709187    
Other Study ID Numbers: DP-CTR208-I-04
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
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