Hypertension
Conditions
Brief summary
The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.
Interventions
DRUGAGSAV301
tablet, q.d.
DRUGExforge 10/160
Tablet, q.d.
Sponsors
Asan Medical Center
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under Curve (AUC) | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours |
| Cmax | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours |
Secondary
| Measure | Time frame |
|---|---|
| AUC (inf) | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours |
| tmax | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours |
| t(1/2β) | 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours |
Countries
South Korea
Outcome results
None listed