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Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT02058472
Recruitment Status : Unknown
Verified February 2014 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2014
Last Update Posted : February 10, 2014
Sponsor:
Collaborator:
Dong-A ST Co., Ltd.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )

Brief Summary:

Study Design : randomized, open label, single-dose, 2-way cross-over design

Phase : Phase I


Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Drug: G3041 Drug: SEVIKAR® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers
Study Start Date : December 2013
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: G3041
Amlodipine orotate 10mg/Olmesartan medoxomil 40mg
Drug: G3041
Drug: SEVIKAR®
Active Comparator: SEVIKAR®
Amlodipine besylate 10mg/Olmesartan medoxomil 40mg
Drug: G3041
Drug: SEVIKAR®



Primary Outcome Measures :
  1. AUClast, Cmax [ Time Frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h ]

Secondary Outcome Measures :
  1. tmax, t1/2, AUCinf, CL/F, Vz/F [ Time Frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h ]
  2. ΔAUEC24, ΔEmax, tEmax [ Time Frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h ]


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

Inclusion Criteria:

  • healthy volunteers between the ages of 19 to 55 years old
  • 19 ≤ BMI ≤ 27
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 4 weeks ago before administration

Exclusion Criteria:

  • Hypersensitivity(or history of hypersensitivity) to amlodipine and olmesartan
  • Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
  • Excessive drinking(exceed alcohol 140g/week)
  • Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
  • Smoking over 10 cigarettes per day

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): NCT02058472


Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: JW Ko, MD, PhD Samsung Medical Center

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02058472     History of Changes
Other Study ID Numbers: G3041_BE_I
First Posted: February 10, 2014    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action