Trial | NCT02974439  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    amlodipine ...

  • Study Participants

    60
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
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 Started
Dec 23
2016
Primary Completion
Mar 21
2017
Study Completion
Mar 21
2017
Last Update
Oct 13
2017

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

Drug Norvasc Tablets 5mg

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

  • Other names: Amlodipine Tablet 5mg

Norvasc Tablets 5mg Active Comparator

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

LANDI-Amlodipine Besylate Tablet 5mg Experimental

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

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

History of allergy or hypersensitivity to amlodipine
Significant history of neurological, cardiovascular, digestive, respiratory, urinary, hematological, dysmetabolism or other diseases (such as psychosis) which is unfavorable to the study
History of postural hypotension
Blood donation or lost more than 400mL blood within 3 months prior to the study
Use of medications within 2 weeks before the study
Volunteer in any other clinical drug study within 3 months prior to this study
Drug abuse or alcohol abuse (220ml beer /day or >5 times in 2 hours)
Smoker (>10 cigarettes/day)
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
Abnormal chest X-ray results with clinical significance
Women of childbearing potential, pregnant and lactating women.
Other unfavorable factors diagnosed by investigators.
No Results Posted