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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01776047
First received: January 23, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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

Phase : Phase I


Condition Intervention Phase
Healthy Male Volunteer
 Drug: Exforge®
Drug: G-0081
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dong-A Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    AUCinf = AUClast + Clast/λz

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

    t1/2 = 0.693/λz



Enrollment: 51
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01776047     History of Changes
Other Study ID Numbers: G-0081_BA_I
Study First Received: January 23, 2013
Last Updated: January 23, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Amlodipine, valsartan drug combination
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013