NCT01776047

Brief Summary

Study Design : randomized, open label, single-dose, 2-way cross-over design Phase : Phase I

Trial Health

100
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

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

July 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

January 23, 2013

Last Update Submit

January 23, 2013

Conditions

Healthy Male Volunteer

Outcome Measures

Primary Outcomes (1)

  • AUClast, Cmax

    Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

Secondary Outcomes (1)

  • AUCinf, Tmax, t1/2, % AUCextra

    Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h

Study Arms (2)

Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)

ACTIVE COMPARATOR

Exforge® 10/160

Drug: Exforge®

G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)

EXPERIMENTAL

G-0081

Drug: G-0081

Interventions

Exforge®DRUG
Exforge® 10/160 (Amlodipine besylate 10mg / Valsartan 160mg)
G-0081DRUG
G-0081 (Amlodipine orotate 10mg / Valsratan 160mg)

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male volunteers between the ages of 20 to 50 years old within the range of ±20% of IBW(Ideal Body Weight)
  • having neither congenital/chronic diseases nor pathological symptoms/findings as results of medical examination
  • doctor determines to be suitable as subjects within 4 weeks ago before administration

You may not qualify if:

  • Hypersensitivity(or history of hypersensitivity) to amlodipine and valsartan
  • Active Liver Diseases or exceed 1.5 times the normal range of AST, ALT
  • Gastrointestinal diseases or surgeries that affect absorption of drug
  • Excessive drinking(exceed 30g/week) and excessive caffeine(exceed 250mg/day)
  • Smoking over 10 cigarettes per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Amlodipine, Valsartan Drug Combination

Intervention Hierarchy (Ancestors)

ValsartanTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmlodipineDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical Preparations

Study Officials

  • K S Park, MD, PhD

    Head of Clinical Development, Clinical Trials Center Severance Hospital

    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

January 23, 2013

First Posted

January 25, 2013

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01