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A Relative Bioavailability Study of 60 mg Nifedipine ER Tablets Under Non-fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00864617
First received: March 18, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study is compare the relative bioavailability of Nifedipine ER tablets 60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by Bayer Pharmaceuticals Corporation, Bayer HealthCare following a single oral dose (1 x 60 mg tablet) in healthy adult volunteers under non-fasting conditions


Condition Intervention Phase
Healthy
Drug: Nifedipine Extended Release tablets 60 mg, single dose
Drug: ADALAT® CC Extended Release Tablets 60 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Non-Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Actavis Inc.:

Primary Outcome Measures:
  • Rate and Extend of Absorption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: May 2005
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Nifedipine Extended Release tablets 60 mg, single dose
Drug: Nifedipine Extended Release tablets 60 mg, single dose
A: Experimental Subjects received Abrica Pharmaceuticals LLLP formulated products under non-fasting conditions
Other Name: Nifedipine
Active Comparator: B
ADALAT® CC Extended Release Tablets 60 mg
Drug: ADALAT® CC Extended Release Tablets 60 mg
B: Active comparator Subjects received Bayer Pharmaceuticals Corporation, Bayer HealthCare formulated products under non-fasting conditions
Other Name: Nifedipine

Detailed Description:

Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under non-fasting conditions

Official Title: A Relative Bioavailability Study of 60 mg Nifedipine Extended Release tablets Under Non-Fasting Conditions

Further study details as provided by Actavis Elizabeth LLC:

Primary Outcome Measures:

Rate and Extend of Absorption

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Screening Demographics: All volunteers selected for this study will be healthy men and women 18 to 45 years of age inclusive at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults -1983 Metropolitan Height and Weight Table.
  2. Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.

    Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.

    The screening clinical laboratory procedures will include:

    • HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential; RBC count, platelet count;
    • CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase;
    • HIV antibody and hepatitis B surface antigen screens;
    • URINALYSIS: by dipstick, microscopic examination if dipstick positive; and.
    • URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
    • SERUM PREGNANCY SCREEN (female volunteers only)
  3. If female and:

    • of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) condom with spermicide, diaphragm with sperriIicide, intrauterine device. (IUD), or abstinence; or
    • is postmenopausal for at least I year; or
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  1. Volunteers with a recent history of drug or alcohol addiction or abuse.
  2. Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the medical investigator).
  3. Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  4. Volunteers demonstrating a positive hepatitis B surface antigen, hepatitis C antibody or HIV antibody.
  5. Volunteers demonstrating a positive drug abuse screen when screened for this study.
  6. Female volunteers demonstrating a positive pregnancy screen.
  7. Female volunteers who are currently breastfeeding.
  8. Volunteers with a history of allergic response(s) to nifedipine or related drugs.
  9. Volunteers with a history of clinically significant allergies including drug allergies.
  10. Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).
  11. Volunteers who currently use tobacco products.
  12. Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 28 days prior to Period I dosing.
  13. Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  14. Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  15. Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
  16. Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
  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: NCT00864617

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Actavis Inc.
Investigators
Principal Investigator: James D. Carlson,, Pharm.D, PRACS Institute, Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier: NCT00864617     History of Changes
Other Study ID Numbers: R05-0100
Study First Received: March 18, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Nifedipine
Healthy subjects

Additional relevant MeSH terms:
Nifedipine
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 19, 2014