Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

Phase 1

Completed

• Conditions: Hypertension
• Interventions: Drug: AGSAV301; Drug: Exforge 10/160

• Registration Number: NCT01536353
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AGSAV301	AGSAV301	-
Exforge 10/160	Exforge 10/160	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of