NCT01536353

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Jan 2012

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 25, 2015

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

February 15, 2012

Last Update Submit

November 24, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

AGSAV301

EXPERIMENTAL
Drug: AGSAV301

Exforge 10/160

ACTIVE COMPARATOR
Drug: Exforge 10/160

Interventions

AGSAV301DRUG

tablet, q.d.

AGSAV301
Exforge 10/160DRUG

Tablet, q.d.

Exforge 10/160

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)"
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 22, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

November 25, 2015

Record last verified: 2012-02

Locations

KR(1)