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

NCT ID: NCT02974439

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-23

Study Completion Date

2017-03-21

Brief Summary

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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

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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.

Conditions

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Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LANDI-Amlodipine Besylate Tablet 5mg

Intervention Type DRUG

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

Norvasc Tablets 5mg

During the study session, healthy subjects will be administered a single dose of Norvasc Tablets 5mg under fasting and FED conditions.

Group Type ACTIVE_COMPARATOR

Norvasc Tablets 5mg

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Norvasc Tablets 5mg

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

Intervention Type DRUG

Other Intervention Names

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Amlodipine Tablet 5mg Amlodipine Tablet 5mg

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Haini Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yanmei Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui Central Hospital

Locations

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Shanghai Haini Pharmaceutical Co., Ltd.

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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HN-LD

Identifier Type: -

Identifier Source: org_study_id