Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Collaborator: Asan Medical Center
• Treatments: Amlodipine, Valsartan Drug Combination

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