Amlodipine 10 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00841542
First received: February 9, 2009
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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 under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Amlodipine Besylate
Drug: Norvasc®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax - Maximum Observed Concentration [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • AUC0-Inf - Area Under the Concentration-Time Curve From Time Zero to Infinity (Extrapolated) [ Time Frame: Blood samples collected over 168 hour period ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: April 2003
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841542

Locations
Canada, Ontario
Biovail Contract Research
Toronto, Ontario, Canada
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Paul Y Tam, MD Biovail Contract Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00841542     History of Changes
Other Study ID Numbers: 2683
Study First Received: February 9, 2009
Results First Received: May 6, 2009
Last Updated: July 6, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 29, 2014