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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02974439

Enrollment

Registered

2016-11-28

Start date

2016-12-23

Completion date

2017-03-21

Last updated

2017-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bioequivalence

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.

Interventions

DRUGLANDI-Amlodipine Besylate Tablet 5mg

LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.

DRUGNorvasc Tablets 5mg

Norvasc Tablet 5mg will be used as a comparator drug for the BE study.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence based on Peak Plasma Concentration (Cmax)	144 hours

Secondary

Measure	Time frame
Bioequivalence based on Area under the plasma concentration versus time curves (AUC)	144 hours

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026