A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776047

Enrollment

Registered

2013-01-25

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Male Volunteer

Brief summary

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

Interventions

DRUGExforge®

DRUGG-0081

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	AUCinf = AUClast + Clast/λz %AUCextra = \[ (AUCinf - AUClast) / AUCinf \] ×100 t1/2 = 0.693/λz

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026