Clinical trial NCT02974439: Bioequivalence Study of Amlodipine and Norvasc Under Fasting and FED Conditions in Chinese Healthy Volunteers
Official title: An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Amlodipine and Norvasc Under Fasting Condition Sand Under Non-fasting(FED) Conditions in Chinese Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Shanghai Haini Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the pharmacokinetics and bioequivalence of Amlodipine Besylate Tablets 5 mg versus Norvasc 5 mg tablets administered as 5 mg tablet in healthy volunteers with a washout period of 14 days

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. History of allergy or hypersensitivity to amlodipine
2. Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
3. History of postural hypotension
4. Blood donation or lost more than 400mL blood within 3 months prior to the study
5. Use of medications within 2 weeks before the study
6. Volunteer in any other clinical drug study within 3 months prior to this study
7. Drug abuse or alcohol abuse (220ml beer /day or \>5 times in 2 hours)
8. Smoker (\>10 cigarettes/day)
9. 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
10. Abnormal chest X-ray results with clinical significance
11. Women of childbearing potential, pregnant and lactating women.
12. Other unfavorable factors diagnosed by investigators.

Primary outcomes:
measure: Bioequivalence based on Peak Plasma Concentration (Cmax)
timeFrame: 144 hours
Secondary outcomes:
measure: Bioequivalence based on Area under the plasma concentration versus time curves (AUC)
timeFrame: 144 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Haini Pharmaceutical Co., Ltd.
Study officials:
affiliation: Shanghai Xuhui Central Hospital
name: Yanmei Liu
role: PRINCIPAL_INVESTIGATOR
References: