NCT02974439

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

December 23, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

November 17, 2016

Last Update Submit

October 12, 2017

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence based on Peak Plasma Concentration (Cmax)

    144 hours

Secondary Outcomes (1)

  • Bioequivalence based on Area under the plasma concentration versus time curves (AUC)

    144 hours

Study Arms (2)

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

LANDI-Amlodipine Besylate Tablet 5mgDRUG

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

Also known as: Amlodipine Tablet 5mg
LANDI-Amlodipine Besylate Tablet 5mg
Norvasc Tablets 5mgDRUG

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

Also known as: Amlodipine Tablet 5mg
Norvasc Tablets 5mg

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Haini Pharmaceutical Co., Ltd.

Shanghai, 201318, China

Location

MeSH Terms

Interventions

Amlodipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yanmei Liu

    Shanghai Xuhui Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 28, 2016

Study Start

December 23, 2016

Primary Completion

March 21, 2017

Study Completion

March 21, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)