Bioavailability of 5 mg of Levamlodipine Maleate Tablets Versus 10 mg of Amlodipine Besylate Tablet in Healthy Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study are (1) to assess the relative bioavailability (BA) of a single oral dose of
      either 5 mg of Levamlodipine Maleate Tablets from CSPC or 10 mg of Amlodipine Besylate Tablet
      (NORVASC®) from Pfizer Inc. under fasting condition in male and female healthy subjects; and
      (2) to evaluate food effect on the PK profile of Levamlodipine Maleate Tablets from CSPC.
    

Detailed description: 
      This study consists of 2 parts:

      Part 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the
      relative BA of levamlodipine maleate tablets from CSPC (Test) versus Amlodipine Besylate
      Tablet NORVASC® from Pfizer Inc. (Reference) after a single oral administration under fasted
      conditions in male and female healthy subjects. Approximately 32 healthy subjects will be
      enrolled in the US to obtain 27 completed subjects.

      Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK
      profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will
      be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing.
      Subjects will receive a single oral administration of study drug under a high-fat /
      high-calorie meal that should derive approximately 150, 250 and 500-600 calories from
      protein, carbohydrate and fat, respectively.
    

Intervention name(s): Levamlodipine, Amlodipine; Amlodipine, Levamlodipine
Intervention type(s): Drug; Drug
Intervention description(s): In Part 1, this group of subjects were treated with a single dose of 5 mg levamlodipine maleate tablets (Test Product), then crossed over to receive a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.; In Part 1, this group of subjects were treated with a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product), and then crossed over to receive a single dose of 5 mg levamlodipine maleate tablets (Test Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.
Other intervention name(s): Xuanning®, NORVASC®; NORVASC®, Xuanning®
Intervention MeSH terms: Niacin; Amlodipine
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study consists of 2 parts. Part 1 will be a randomized, open-label, single-dose, two-way crossover study to assess the relative BA of levamlodipine maleate tablets from CSPC versus Amlodipine Besylate Tablet NORVASC® from Pfizer Inc. after a single oral administration under fasted conditions in male and female healthy subjects. Part 2 will be a single-arm, open-label, single-dose phase to assess food effect on the PK profile of levamlodipine maleate tablets from CSPC. Subjects who have completed Part 1 will be rolled over to Part 2 after a wash-out period for at least 14-days since the last dosing. Subjects will receive a single oral administration of study drug under a high-fat / high-calorie meal that should derive approximately 150, 250 and 500-600 calories from protein, carbohydrate and fat, respectively.
Masking: None (Open Label)
Primary purpose: Treatment