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Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

This study is currently recruiting participants.
Verified February 2012 by Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01536353
First received: February 15, 2012
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.


Condition Intervention Phase
Hypertension
 Drug: AGSAV301
Drug: Exforge 10/160
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Dose, Randomized, Open-label, 2x2 Crossover Study to Evaluate the Bioavailability and Safety of AGSAV301 Tablet in Healthy Male Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Area Under Curve (AUC) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC (inf) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours ] [ Designated as safety issue: No ]
  • tmax [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours ] [ Designated as safety issue: No ]
  • t(1/2β) [ Time Frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AGSAV301 Drug: AGSAV301
tablet, q.d.
Active Comparator: Exforge 10/160 Drug: Exforge 10/160
Tablet, q.d.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult males 20 to 40 years at screening.
  • body weight ≥ 45kg and within ± 20% of the ideal body weight : Ideal body weight = (height [cm] - 100) x 0.9
  • Be able to collect blood for study and visit for follow-up period
  • Subject who agrees to participate in this study and give written informed consent

Exclusion Criteria:

  • Have history of significant hepatic, renal, gastrointestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hematologic, cardiovascular diseases
  • Have a gastrointestinal disease(ex : Crohn's disease, gastrointestinal ulcer)or surgery(except for Appendectomy, Hernia repair) affected the absorption of medications
  • Inappropriate in Screening test (interview, vital sigh, BP, 12-lead ECG, laboratory test etc.)
  • Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of amlodipine or valsartan
  • drug abuse, or have a history of drug abuse showed a positive for the screening test on urine : amphetamine, barbiturate, cocaine, opiates, benzodiazepines, cannabinoids, methadone etc.
  • Subject who takes herbal medicine within 30 days, ethical drug within 14 days, OTC within 7 days before the beginning of administration of investigational drug
  • Unusual diet affected the absorption, distribution, metabolism, excretion of medications
  • Subject who treated with any investigational drugs within 60 days before the administration of investigational drug
  • Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
  • Subject who takes inhibitors and inducers of drug metabolizing enzyme (Barbiturates etc.) within 30days
  • Subject who have taken habitually caffeine (caffeine > 5 units/day)
  • Subject who have drunken habitually (alcohol > 21 units/week, 1 unit = pure alcohol 10ml)or who are unable to quit drinking during this study or smoker
  • positive for Hepatitis B, Hepatitis C, HIV or Syphilis
  • Blood Pressure is not in the range of "140 > sitting SBP ≥ 90mmHg, 90 > sitting DBP ≥ 60mmHg"
  • Pulse rate is not in the range of "95 > sitting Pulse Rate ≥ 45bpm (beats per minute)"
  • AST, ALT, total bilirubin over twice of reference range
  • Subjects deemed ineligible by investigator based on other reasons
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536353

Contacts
Contact: Sang-Young Yoon, Manager +82-2-3289-4257 syyoon@ahn-gook.com
Contact: Jin-Hyung Kim, Researcher +82-2-3289-4362 jhkim04@ahn-gook.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin-Hyung Kim     +82-2-3289-4362        
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
Asan Medical Center
Investigators
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Asan Medical Center
  More Information

No publications provided

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01536353     History of Changes
Other Study ID Numbers: 1110-AGSAV-P1
Study First Received: February 15, 2012
Last Updated: February 21, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine, valsartan drug combination
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013