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

Healthy Adult Volunteers Clinical Trial

Official title:

An Open Label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety Following Administration of G3041 and SEVIKAR® Tablet in Healthy Adult Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02058472
• Other study ID #: G3041_BE_I
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 6, 2014
• Last updated: February 6, 2014
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea : Korea Ministry of Food and Drug Safety
• 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: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 55 Years

Eligibility

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, ?-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

Study Design

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

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• G3041

• SEVIKAR®

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast, Cmax		Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h	No
Secondary	tmax, t1/2, AUCinf, CL/F, Vz/F		Blood gathering point : 0h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 7h, 8h, 12h, 24h, 48h, 72h	No
Secondary	?AUEC24, ?Emax, tEmax		0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h	No