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
Results First Received: June 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy Volunteers
Interventions: Drug: Amlodipine - reference
Drug: Amlodipine ODT - test

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.

Participant Flow for 5 periods

Period 1:   First Intervention Period
    Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water     Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT     Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet     Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water     Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT     Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet  
STARTED     3     3     3     3     3     3  
COMPLETED     3     3     3     3     3     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Washout Period I (of 16 Days)
    Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water     Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT     Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet     Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water     Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT     Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet  
STARTED     3     3     3     3     3     3  
COMPLETED     2     2     3     3     2     3  
NOT COMPLETED     1     1     0     0     1     0  
Lost to Follow-up                 1                 1                 0                 0                 1                 0  

Period 3:   Second Intervention Period
    Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water     Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT     Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet     Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water     Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT     Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet  
STARTED     2     2     3     3     2     3  
COMPLETED     2     2     3     3     2     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 4:   Washout Period II (of 16 Days)
    Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water     Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT     Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet     Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water     Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT     Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet  
STARTED     2     2     3     3     2     3  
COMPLETED     2     2     3     3     2     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 5:   Third Intervention Period
    Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water     Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT     Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet     Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water     Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT     Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet  
STARTED     2     2     3     3     2     3  
COMPLETED     2     2     3     3     2     3  
NOT COMPLETED     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Entire Study Population All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  27.22  ± 7.22  
Gender  
[units: participants]
 
Female     0  
Male     18  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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