Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301

NCT ID: NCT01536353

Last Updated: 2015-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-08-31

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AGSAV301

Group Type: EXPERIMENTAL

AGSAV301

Intervention Type: DRUG

tablet, q.d.

Exforge 10/160

Group Type: ACTIVE_COMPARATOR

Exforge 10/160

Intervention Type: DRUG

Tablet, q.d.

Interventions

AGSAV301

tablet, q.d.

Intervention Type: DRUG

Exforge 10/160

Tablet, q.d.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Asan Medical Center

OTHER

Sponsor Role: collaborator

Ahn-Gook Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyun-Seop Bae, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1110-AGSAV-P1

Identifier Type: -

Identifier Source: org_study_id