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

Bioequivalence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974439
• Other study ID #: HN-LD
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2016
• Last updated: October 12, 2017
• Start date: December 23, 2016
• Est. completion date: March 21, 2017

Study information

• Verified date: October 2017
• Source: Shanghai Haini Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 21, 2017
• Est. primary completion date: March 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bioequivalence

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Haini Pharmaceutical Co., Ltd.	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Haini Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence based on Peak Plasma Concentration (Cmax)		144 hours
Secondary	Bioequivalence based on Area under the plasma concentration versus time curves (AUC)		144 hours