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

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

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: LANDI-Amlodipine Besylate Tablet 5mg; Drug: Norvasc Tablets 5mg

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201318
    • Shanghai Haini Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LANDI-Amlodipine Besylate Tablet 5mg; During the study session, healthy subjects will be administered a single dose of LANDI-AmlodipineTablet 5mg under fasting and FED conditions.	Drug: LANDI-Amlodipine Besylate Tablet 5mg; LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.; Other Names: Amlodipine Tablet 5mg
Active Comparator: Norvasc Tablets 5mg; During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions.	Drug: Norvasc Tablets 5mg; Norvasc Tablet 5mg will be used as a comparator drug for the BE study.; Other Names: Amlodipine Tablet 5mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Haini Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Yanmei Liu, Shanghai Xuhui Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Actual): March 21, 2017
• Study Completion (Actual): March 21, 2017

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: HN-LD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No