Status:
COMPLETED
Amlodipine 10 mg Tablets Under Fed Conditions
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets unde...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening).
- Body Mass Index (BMI = weight/height2) greater than or equal to 19.0 kg.m2 and less than or equal to 30.0 kg/m2.
- Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 106-140/66-90 mmHg, heart rate between 55-99 beats/min).
- Negative for drugs of abuse, nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).
- No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.
- Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.
- Exclusion Criteria
- Known history of hypersensitivity to amlodipine (e.g. Norvasc®) and/or related drugs such as nifedipine, diltiazem HCl, verapamil or felodipine.
- Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.
- Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness during the last four weeks prior to entry into this study.
- Presence of any significant physical or organ abnormality.
- Any subject with a history of drug abuse.
- Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.
- Use of any prescription medication within 14 days preceding entry into this study.
- Use of over the counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).
- Female subjects: use of contraceptives (oral, transdermal, implant, Mirena® IUD) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.
- Female subjects: presence of pregnancy or lactation.
- Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.
- Participation in a clinical trial with an investigational drug within 30 days preceding this study.
- Any subject who has donated blood within 56 days preceding this study.
- Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.
- Significant or recent history of asthma (after 12 years of age).
- Any subject with a recent (less than one year) history of alcohol abuse.
- Known history of frequent headaches or migraines.
- Intolerance to venipuncture.
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00841815
Start Date
April 1 2003
End Date
May 1 2003
Last Update
August 20 2024
Active Locations (1)
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1
Biovail Contract Research
Toronto, Ontario, Canada