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A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01776047
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : January 25, 2013
Sponsor:
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 Male Volunteer Drug: Exforge® Drug: G-0081 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Active Comparator: Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)
Exforge® 10/160
Drug: Exforge®
Experimental: G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)
G-0081
Drug: G-0081



Primary Outcome Measures :
  1. AUClast, Cmax [ Time Frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h ]

Secondary Outcome Measures :
  1. AUCinf, Tmax, t1/2, % AUCextra [ Time Frame: Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h ]

    AUCinf = AUClast + Clast/λz

    %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100

    t1/2 = 0.693/λz




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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
  • 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 valsartan
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/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): NCT01776047


Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: K S Park, MD, PhD Head of Clinical Development, Clinical Trials Center Severance Hospital

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01776047     History of Changes
Other Study ID Numbers: G-0081_BA_I
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Amlodipine
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents