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Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01536353
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : November 25, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2012
Primary Completion Date : April 2012
Study Completion Date : August 2012
Arms and Interventions

Arm Intervention/treatment
Experimental: AGSAV301 Drug: AGSAV301
tablet, q.d.
Active Comparator: Exforge 10/160 Drug: Exforge 10/160
Tablet, q.d.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

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): NCT01536353


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
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

Responsible Party: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01536353     History of Changes
Other Study ID Numbers: 1110-AGSAV-P1
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: February 2012

Additional relevant MeSH terms:
Amlodipine, Valsartan Drug Combination
Antihypertensive Agents