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Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

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ClinicalTrials.gov Identifier: NCT01138826
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : July 20, 2011
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
Aurobindo Pharma Ltd
Trident Life Sciences Ltd.
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Amlodipine - reference Drug: Amlodipine ODT - test Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions
Study Start Date : May 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: treatment A - reference w/ water Drug: Amlodipine - reference
10 mg tablet, single dose, with water
Experimental: Treatment B - ODT (test) w/ water Drug: Amlodipine ODT - test
10 mg orally disintegrating tablet (ODT), single dose, with water
Experimental: Treatment C - ODT (test) w/o water Drug: Amlodipine ODT - test
10 mg orally disintegrating tablet (ODT), single dose, without water


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)] [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ]
    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-∞).

  2. AUC From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ]
    Area under the plasma concentration-time curve from time zero (pre-dose) to the time of the last measurable concentration (AUClast).

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ]

Secondary Outcome Measures :
  1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, and 168 hours post dose ]
  2. Plasma Decay Half-Life (t1/2) [ Time Frame: 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 is the time measured for the plasma concentration to decrease by one half.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138826


Locations
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India
Pfizer Investigational Site
Hydrabad, Andhra Pradesh, India, 500 050
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Aurobindo Pharma Ltd
Trident Life Sciences Ltd.
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier: NCT01138826    
Other Study ID Numbers: A0531095
051-10
First Posted: June 7, 2010    Key Record Dates
Results First Posted: July 20, 2011
Last Update Posted: January 28, 2021
Last Verified: January 2021
Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):
biological availability
bioavailability
amlodipine
 orally disintegrating tablet
ODT
tablets
Additional relevant MeSH terms:
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Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents