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DP-R212 Pharmacokinetic Study Phase I

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: NCT02814500
Recruitment Status : Unknown
Verified June 2016 by Alvogen Korea.
Recruitment status was:  Not yet recruiting
First Posted : June 27, 2016
Last Update Posted : June 27, 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-R212

Condition or disease Intervention/treatment Phase
Healthy Drug: DP-R212 Drug: Amlodipine Drug: Rosuvastatin Phase 1

Detailed Description:
An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of DP-R212, a fixed dose combination compared with coadministration of separate constituents in healthy adult volunteers

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DP-R212 Pharmacokinetic Study Pharmacokinetic Characteristics of DP-R212 in Comparison to Each Component Coadministered in Healthy Volunteers
Study Start Date : July 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A group
Amlodipine and Rosuvastatin, DP-R212
Drug: DP-R212
Investigational product is prescribed to all of randomized subjects

Drug: Amlodipine
Investigational product is prescribed to all of randomized subjects

Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects

Experimental: B group
DP-R212, Amlodipine and Rosuvastatin
Drug: DP-R212
Investigational product is prescribed to all of randomized subjects

Drug: Amlodipine
Investigational product is prescribed to all of randomized subjects

Drug: Rosuvastatin
Investigational product is prescribed to all of randomized subjects




Primary Outcome Measures :
  1. AUClast [ Time Frame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr ]
  2. Cmax [ Time Frame: 0,0.5,1, 2, 3, 4, 5, 6, 8, 10, 12, 24,48,72 hr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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 30 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): NCT02814500


Contacts
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Contact: Min-Geol Kim, M.D mgkim@jbcp.kr

Sponsors and Collaborators
Alvogen Korea

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Responsible Party: Alvogen Korea
ClinicalTrials.gov Identifier: NCT02814500     History of Changes
Other Study ID Numbers: DP-CTR-212-I-02
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Amlodipine
Rosuvastatin Calcium
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors