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Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Last updated on November 12, 2019

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Study Location
Pfizer Investigational Site
Minato-ku, Tokyo, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy;

- Body Mass Index (BMI) of 18 to 28 kg/m2;

- total body weight within the range of 50 to 100 kg

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History of regular alcohol consumption exceeding 14 drinks/week

- Use of tobacco- or nicotine-containing products in excess of the equivalent of 10
cigarettes per day

NCT01004614
Pfizer
Completed
Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

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Descriptive Information
Brief Title  ICMJE Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
Official Title  ICMJE An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
Brief SummaryThis study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Amlodipine
    3rd OD 5 mg tablet single oral dose administered with water
  • Drug: Amlodipine
    2nd OD 5 mg tablet single oral dose administered with water
  • Drug: Amlodipine
    3rd OD 5 mg tablet single oral dose administered without water
  • Drug: Amlodipine
    2nd OD 5 mg tablet single oral dose administered without water
Study Arms  ICMJE
  • Experimental: Cohort 1
    24 subjects (12 subjects per sequence) will receive treatment A) one 5 mg amlodipine 3rd OD tablet (test) with water and treatment B) one 5 mg amlodipine 2nd OD tablet (reference) with water.
    Interventions:
    • Drug: Amlodipine
    • Drug: Amlodipine
  • Active Comparator: Cohort 2
    24 subjects (12 subjects per sequence) will receive treatment C) one 5 mg amlodipine 3rd OD tablet (test) without water, and treatment D) one 5 mg amlodipine 2nd OD tablet (reference) without water
    Interventions:
    • Drug: Amlodipine
    • Drug: Amlodipine
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2009)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion DateDecember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy;
  • Body Mass Index (BMI) of 18 to 28 kg/m2;
  • total body weight within the range of 50 to 100 kg

Exclusion Criteria:

  • History of regular alcohol consumption exceeding 14 drinks/week
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 10 cigarettes per day
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004614
Other Study ID Numbers  ICMJE A0531088
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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