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Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01177293
First Posted: August 6, 2010
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aurobindo Pharma
Trident Life Sciences Ltd.
Information provided by:
Pfizer
  Purpose
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 capsule.

Condition Intervention Phase
Healthy Volunteers Drug: Amlodipine - reference Drug: Amlodipine ODT - test Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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-∞).

  • Area Under the Curve 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).

  • 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:
  • 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 ]
  • 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.


Enrollment: 14
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment A - reference w/ water Drug: Amlodipine - reference
Amlodipine capsule, 10 mg, single dose, with water
Experimental: Treatment B - ODT (test) w/o water Drug: Amlodipine ODT - test
Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water

  Eligibility

Information from the National Library of Medicine

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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 literate 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 17.5 to 26.4 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
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): NCT01177293


Locations
India
Pfizer Investigational Site
Hydrabad, Andhra Pradesh, India, 500 050
Sponsors and Collaborators
Pfizer
Aurobindo Pharma
Trident Life Sciences Ltd.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01177293     History of Changes
Other Study ID Numbers: A0531096
052-10
First Submitted: March 10, 2010
First Posted: August 6, 2010
Results First Submitted: June 28, 2011
Results First Posted: August 30, 2011
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
biological availability
bioavailability
amlodipine
orally disintegrating tablet
ODT
tablets

Additional relevant MeSH terms:
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents