Bioequivalence Study of Amlodipine and Norvasc Under Fast... | NCT02974439

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

NCT02974439

Sponsor

Shanghai Haini Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Oct 13, 2017Actual

Enrollment

60Actual

Phase

Phase 1

Conditions

Bioequivalence

Interventions

LANDI-Amlodipine Besylate Tablet 5mg
Norvasc Tablets 5mg

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2016Actual

Primary Completion Date

Mar 21, 2017Actual

Completion Date

Mar 21, 2017Actual

First Submitted Date

Nov 17, 2016

First Submission Date that Met QC Criteria

Nov 25, 2016

First Posted Date

Nov 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2017

Last Update Posted Date

Oct 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: LANDI-Amlodipine Besylate 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.	Drug: Norvasc Tablets 5mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LANDI-Amlodipine Besylate Tablet 5mg	Drug	LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.

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

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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds