Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

Ahn-Gook Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Hypertension

Treatments

Drug: Exforge 10/160

Drug: AGSAV301

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01536353

1110-AGSAV-P1

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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