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

Healthy Male Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776047
• Other study ID #: G-0081_BA_I
• Status: Completed
• Phase: Phase 1
• First received: January 23, 2013
• Last updated: January 23, 2013
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2013
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Phase : Phase I

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Male Volunteer

Intervention

Drug:
• Exforge®

• G-0081

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	AUCinf, Tmax, t1/2, % AUCextra	AUCinf = AUClast + Clast/?z; %AUCextra = [ (AUCinf - AUClast) / AUCinf ] ×100; t1/2 = 0.693/?z	Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h, 96h, 144h, 192h	No