NCT01138826

Brief Summary

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started May 2010

Shorter than P25 for phase_1 healthy-volunteers

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

March 8, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2011

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

March 8, 2010

Results QC Date

June 21, 2011

Last Update Submit

January 26, 2021

Conditions

Healthy Volunteers

Keywords

biological availabilitybioavailabilityamlodipineorally disintegrating tabletODTtablets

Outcome Measures

Primary Outcomes (3)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]

    AUC (0-∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).

    0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

  • AUC From Time Zero to Last Quantifiable Concentration (AUClast)

    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

    0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

  • Maximum Observed Plasma Concentration (Cmax)

    0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Secondary Outcomes (2)

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

  • Plasma Decay Half-Life (t1/2)

    0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose

Study Arms (3)

treatment A - reference w/ water

ACTIVE COMPARATOR
Drug: Amlodipine - reference

Treatment B - ODT (test) w/ water

EXPERIMENTAL
Drug: Amlodipine ODT - test

Treatment C - ODT (test) w/o water

EXPERIMENTAL
Drug: Amlodipine ODT - test

Interventions

Amlodipine - referenceDRUG

10 mg tablet, single dose, with water

treatment A - reference w/ water
Amlodipine ODT - testDRUG

10 mg orally disintegrating tablet (ODT), single dose, with water

Treatment B - ODT (test) w/ water

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 18 to 26 kg/m2; and a total body weight \>50 kg (110 lbs).

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Hydrabad, Andhra Pradesh, 500 050, India

Location

Related Links

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

March 8, 2010

First Posted

June 7, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

January 28, 2021

Results First Posted

July 20, 2011

Record last verified: 2021-01

Locations

IN(1)