Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 5mg amlodipine (one LANDI-Amlodipine Tablet 5mg or one Norvasc Tablet 5mg) under fasting and FED conditions.

Inclusion criteria

• Healthy adult volunteers of 18-40 years old, male or female.
• Body mass index (BMI) ranges from 19.0 to 25.0 kg/m2, body weight ≥ 50 kg for male and 45 kg for female.
• No history of heart, liver, kidney, gastrointestinal tract diseases, nervous system, neural abnormities or metabolic abnormalities; No preparation allergies, serious infection or injury, etc.
• Medically healthy subjects with clinically normal laboratory profiles and ECGs.
• Subjects must agree to take effective contraceptive methods to prevent pregnancy from the start of screening until 3 months of last dose administration
• Subjects are fully informed and voluntarily consent to participate in this study.

Exclusion criteria

• History of allergy or hypersensitivity to amlodipine
• Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
• History of postural hypotension
• Blood donation or lost more than 400mL blood within 3 months prior to the study
• Use of medications within 2 weeks before the study
• Volunteer in any other clinical drug study within 3 months prior to this study
• Drug abuse or alcohol abuse (220ml beer /day or >5 times in 2 hours)
• Smoker (>10 cigarettes/day)
• A positive result in hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, a syphilis test, or an human immunodeficiency virus (HIV) test
• Abnormal chest X-ray results with clinical significance
• Women of childbearing potential, pregnant and lactating women.
• Other unfavorable factors diagnosed by investigators.