Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the comparative bioavailability of two fixed dose
      combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects
      will receive each of the following three treatments administered in a randomized three-way
      crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg
      losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg
      losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg
      losartan; all three treatments will be administered once orally and in a fasted state. Serial
      blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of
      amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite).
      Safety assessments will include measurements of orthostatic vital signs, electrocardiograms
      (ECG), collection of adverse events (AE) and clinical laboratory tests.
    

Detailed description: 
      Amlodipine and losartan are calcium channel and angiotensin II receptor type-1 blockers,
      respectively, and are established treatments to manage blood pressure (BP) levels for
      patients with hypertension; both medications are currently marketed in the United States and
      Europe as anti-hypertensive agents. This is a an open-label, randomized, single dose,
      three-way crossover study enrolling 24 healthy adult male and female subjects under fasting
      conditions. Each subject will participate in three treatment periods. The study consists of a
      screening phase, three treatment periods and a follow-up visit. Subjects will receive each of
      the following three treatments administered in a randomized three-way crossover design: a
      reference treatment consisting of a single 5mg amlodipine tablet and a single 100mg losartan
      tablet; a single fixed dose combination tablet consisting of 5mg amlodipine and 100mg
      losartan; and another single fixed dose combination tablet consisting of 5mg amlodipine and
      100mg losartan; all three treatments will be administered once orally and in a fasted state.
      Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis
      of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite).
      Safety assessments will include measurements of orthostatic vital signs, electrocardiograms
      (ECG), collection of adverse events (AE) and clinical laboratory tests.
    

Intervention name(s): Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state; Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state; Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state; 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state; 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Other intervention name(s): GSK2944406; GSK2944406; GSK2944406
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer