Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteers
Treatments
Drug: Amlodipine - reference
Drug: Amlodipine ODT - test
Details and patient eligibility
About
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 capsule.
Enrollment
14 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 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 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.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
14 participants in 2 patient groups
treatment A - reference w/ water
Active Comparator group
Treatment:
Drug: Amlodipine - reference
Treatment B - ODT (test) w/o water
Experimental group
Treatment:
Drug: Amlodipine ODT - test
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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