Clinical trial NCT01536353: Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
First posted: 2012-02-22
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Area Under Curve (AUC)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours
measure: Cmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours
Secondary outcomes:
measure: AUC (inf)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120,168 hours
measure: tmax
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours
measure: t(1/2β)
timeFrame: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10 ,12, 16, 24, 36, 48, 72, 96, 120, 168 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: