Amlodipine 10 mg Tablets Under Fed Conditions
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00841815 |
Recruitment Status
:
Completed
First Posted
: February 11, 2009
Results First Posted
: August 18, 2009
Last Update Posted
: August 18, 2009
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Amlodipine Besylate Drug: Norvasc® | Phase 1 |
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects |
Study Start Date : | April 2003 |
Actual Primary Completion Date : | May 2003 |
Actual Study Completion Date : | May 2003 |
Arm | Intervention/treatment |
---|---|
Experimental: Amlodipine Besylate
Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
|
Drug: Amlodipine Besylate
10 mg Tablet
|
Active Comparator: Norvasc®
Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
|
Drug: Norvasc®
10 mg Tablet
|
- Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 168 hour period ]
- AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 168 hour period ]
- AUC0-t - Area Under the Concentration-Time Curve From Time Zero to Time of Last Non-Zero Concentration (Per Participant) [ Time Frame: Blood samples collected over 168 hour period ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841815
Canada, Ontario | |
Biovail Contract Research | |
Toronto, Ontario, Canada |
Principal Investigator: | Paul Y Tam, MD | Biovail Contract Research |
ClinicalTrials.gov Identifier: | NCT00841815 History of Changes |
Other Study ID Numbers: |
2684 |
First Posted: | February 11, 2009 Key Record Dates |
Results First Posted: | August 18, 2009 |
Last Update Posted: | August 18, 2009 |
Last Verified: | July 2009 |
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
Amlodipine Antihypertensive Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents |