Pharmacokinetic/Pharmacodynamic & Safety Study of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

Dong-A Pharmaceutical

Status and phase: Unknown; Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Drug: G3041; Drug: SEVIKAR®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02058472

G3041_BE_I

Details and patient eligibility

About

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

Phase : Phase I

Enrollment: 30 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers between the ages of 19 to 55 years old
• 19 ≤ BMI ≤ 27
• 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 olmesartan
• Exceed 1.5 times of the upper limit of the reference range of AST, ALT, total bilirubin, γ-GT
• Excessive drinking(exceed alcohol 140g/week)
• Excessive caffeine(exceed 4cups/day) and grape fruit/orange juice(exceed 1cup/day)
• Smoking over 10 cigarettes per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

G3041

Experimental group

Description:

Amlodipine orotate 10mg/Olmesartan medoxomil 40mg

Treatment:

Drug: SEVIKAR®

Drug: G3041

SEVIKAR®

Active Comparator group

Description:

Amlodipine besylate 10mg/Olmesartan medoxomil 40mg

Treatment:

Drug: SEVIKAR®

Drug: G3041