Status:
COMPLETED
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborating Sponsors:
Aurobindo Pharma Ltd
Trident Life Sciences Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 bioavailabil...
Eligibility Criteria
Inclusion
- Healthy male and/or female literate 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 17.5 to 26.4 kg/m2; and a total body weight \>50 kg (110 lbs).
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01177293
Start Date
March 1 2010
End Date
June 1 2010
Last Update
January 28 2021
Active Locations (1)
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1
Pfizer Investigational Site
Hydrabad, Andhra Pradesh, India, 500 050