NCT01797926View on ClinicalTrials.gov

Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions

PHASE1CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

May 23, 2013

Primary Completion Date

July 25, 2013

Study Completion Date

July 25, 2013

Conditions
Hypertension
Interventions
DRUG

Reference Treatment: 5 mg amlodipine + 50 mg losartan

Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 50 mg losartan tablet administered orally in fasted state as a single dose

DRUG

Reference Treatment:5 mg amlodipine + 100 mg losartan

Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 100 mg losartan tablet administered orally in fasted state as a single dose

DRUG

FDC 5/50 amlodipine/ losartan

Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 50 mg losartan in fasted state

DRUG

FDC 5/100 amlodipine /losartan

Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 100 mg losartan in fasted state

Trial Locations (1)

9301

GSK Investigational Site, Bloemfontein

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01797926 - Study to Determine the Bioequivalence of Two Fixed Dose Combination (FDC) Tablet Formulations of Amlodipine and Losartan FDC5/50 and FDC5/100 Under Fasting Conditions | Biotech Hunter | Biotech Hunter