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

This study has been completed.
Sponsor:
Collaborators:
Aurobindo Pharma Limited
Trident Life Sciences Limited
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01138826
First received: March 8, 2010
Last updated: June 21, 2011
Last verified: June 2011
  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 (non-ODT) tablet.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

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 ] [ Designated as safety issue: No ]
    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-∞).

  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.


Enrollment: 18
Study Start Date: May 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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138826

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01138826     History of Changes
Other Study ID Numbers: A0531095, 051-10
Study First Received: March 8, 2010
Results First Received: June 21, 2011
Last Updated: June 21, 2011
Health Authority: India: Drugs Controller General of India

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

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

ClinicalTrials.gov processed this record on August 28, 2014