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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

March 8, 2010
June 21, 2011
May 2010
June 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • AUC (infinity) of amlodipine [ Time Frame: Hours 1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120,168 ] [ Designated as safety issue: No ]
  • AUC (last) of amlodipine [ Time Frame: Hours 1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120,168 ] [ Designated as safety issue: No ]
  • Cmax of amlodipine [ Time Frame: Hours 1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120,168 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01138826 on ClinicalTrials.gov Archive Site
  • 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.
  • Tmax of amlodipine [ Time Frame: Hours 1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120,168 ] [ Designated as safety issue: No ]
  • Half-life of amlodipine [ Time Frame: Hours 1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120,168 ] [ Designated as safety issue: No ]
  • Safety laboratory tests- hematology, chemistry, urinanalysis, FSH, serum bhCG, urine drug screen. [ Time Frame: screening (a variable time period); at discharge (a variable time period) ] [ Designated as safety issue: Yes ]
  • Vital signs-blood pressure, pulse rate [ Time Frame: screening (a variable time period); predose; 2,4,6,8,10,12,24,36,48,72,96,120 hours postdose ] [ Designated as safety issue: Yes ]
  • Adverse events- any untoward medical occurrence in a clinical investigation subject administered a product or medical device [ Time Frame: Day 0, predose, 0,1,2,3,4,6,8,10,12,14,16,24,36,48,72,96,120, and 168 hours postdose ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Amlodipine - reference
    10 mg tablet, single dose, with water
  • Drug: Amlodipine ODT - test
    10 mg orally disintegrating tablet (ODT), single dose, with water
  • Drug: Amlodipine ODT - test
    10 mg orally disintegrating tablet (ODT), single dose, without water
  • Active Comparator: treatment A - reference w/ water
    Intervention: Drug: Amlodipine - reference
  • Experimental: Treatment B - ODT (test) w/ water
    Intervention: Drug: Amlodipine ODT - test
  • Experimental: Treatment C - ODT (test) w/o water
    Intervention: Drug: Amlodipine ODT - test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01138826
A0531095, 051-10
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
  • Aurobindo Pharma Limited
  • Trident Life Sciences Limited
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP