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

• ClinicalTrials.gov Identifier: NCT02974439
• Recruitment Status: Completed
• First Posted: November 28, 2016
• Last Update Posted: October 13, 2017
• Sponsor: Shanghai Haini Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Shanghai Haini Pharmaceutical Co., Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Bioequivalence	Drug: LANDI-Amlodipine Besylate Tablet 5mg; Drug: Norvasc Tablets 5mg	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 23, 2016
• Actual Primary Completion Date: March 21, 2017
• Actual Study Completion Date: March 21, 2017

Arms and Interventions

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 Name: 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 Name: Amlodipine Tablet 5mg

Outcome Measures

Primary Outcome Measures :

1. Bioequivalence based on Peak Plasma Concentration (Cmax) [ Time Frame: 144 hours ]

Secondary Outcome Measures :

1. Bioequivalence based on Area under the plasma concentration versus time curves (AUC) [ Time Frame: 144 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China

Shanghai Haini Pharmaceutical Co., Ltd.

Shanghai, China, 201318

Sponsors and Collaborators

Shanghai Haini Pharmaceutical Co., Ltd.

Investigators

• Principal Investigator: Yanmei Liu; Shanghai Xuhui Central Hospital

More Information

• Responsible Party: Shanghai Haini Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02974439
• Other Study ID Numbers: HN-LD
• First Posted: November 28, 2016
• Last Update Posted: October 13, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Amlodipine; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents