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

Last updated on December 6, 2018

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Study Location
Pfizer Investigational Site
Hydrabad, Andhra Pradesh, 500 050 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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.

NCT01138826
Pfizer
Completed
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

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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
Intervention Model: Crossover Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01138826
A0531095
051-10
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
  • Aurobindo Pharma
  • Trident Life Sciences Ltd.
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

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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.

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1-800-718-1021

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