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
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a three-period, three sequence, reference replicated, cross-over study to determine
      the bioequivalence of two amlodipine and losartan FDC tablet formulations FDC5/50 and
      FDC5/100 (GSK2944406; 5 mg amlodipine and 50 mg and 100 mg losartan) to reference amlodipine
      and losartan tablets co-administered in two groups enrolling 102 healthy adult male and
      female subjects under fasting conditions.

      A description of each treatment is provided below:

      A (Reference) = 1 x 5 mg amlodipine tablet and 1 x 50 mg losartan tablet. B (FDC5/50) = 1 x 5
      mg amlodipine and 50 mg losartan tablet C (Reference) = 1 x 5 mg amlodipine tablet and 1 x
      100 mg losartan tablet D (FDC5/100) = 1 x 5 mg amlodipine and100 mg losartan tablet The
      treatments will be administered in accordance with the randomisation schedule as.

      Group 1: A → A → B or A → B → A or B → A → A Group 2: C → C → D or C → D → C or D → C → C All
      subjects will attend a screening visit within 28 days of their first dosing period (Day 1).
      The baseline assessments will be conducted the day before the first dosing.

      In each treatment period, subjects will be admitted to the clinic in the evening before Day
      1. All subjects will receive a single oral dose of amlodipine and losartan in the morning on
      Day 1. All the subjects will remain in the clinical unit until completion of all assessments
      at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample.
      Subjects will return to the clinic for pharmacokinetic samples at 36, 48, 72 and 96 hours
      post-dose.

      The three treatment periods will be separated by a washout period of 10-17 days. Upon
      completion of the last dosing period, or early withdrawal, subjects will return to the
      clinical unit within 14-21 days for a follow up visit.
    


Intervention name(s): Reference Treatment: 5 mg amlodipine + 50 mg losartan; Reference Treatment:5 mg amlodipine + 100 mg losartan; FDC 5/50 amlodipine/ losartan; FDC 5/100 amlodipine /losartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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; 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; Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 50 mg losartan in fasted state; Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 100 mg losartan in fasted state
Intervention MeSH terms: Losartan; Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; Hypertension; losartan; healthy volunteers; amlodipine