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

Dong-A Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteer

Treatments: Drug: G-0081; Drug: Exforge®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01776047

G-0081_BA_I

Details and patient eligibility

About

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

Phase : Phase I

Enrollment: 51 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

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

Active Comparator group

Description:

Exforge® 10/160

Treatment:

Drug: Exforge®

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

Experimental group

Description:

G-0081

Treatment:

Drug: G-0081