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 ST 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

Further study details as provided by Dong-A ST 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776047

Sponsors and Collaborators
Dong-A ST 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 ST 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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014