NCT01536353CompletedPhase 1
A Single Dose, Randomized, Open-label, 2x2 Crossover Study to Evaluate the Bioavailability and Safety of AGSAV301 Tablet in Healthy Male Volunteers
Ahn-Gook Pharmaceuticals Co.,Ltd1 site in 1 country30 target enrollmentStarted: January 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Area Under Curve (AUC)
Study Overview
Brief Summary
The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
AGSAV301
Experimental
Intervention: AGSAV301 (Drug)
Exforge 10/160
Active Comparator
Intervention: Exforge 10/160 (Drug)
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)
Investigators
Study Sites (1)
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