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Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

Last updated on December 16, 2017

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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.
Show details

- 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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Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet
An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
This 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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2009
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01004614
A0531088
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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