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

A Relative Bioavailability Study of 60 mg Nifedipine Extended Release Tablets Under Non-Fasting Conditions

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nifedipine Extended Release tablets 60 mg, single dose; Drug: ADALAT® CC Extended Release Tablets 60 mg

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Fargo, North Dakota, United States, 58102
      • PRACS Institute, Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Nifedipine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate and Extend of Absorption	48 hours

Collaborators and Investigators

• Sponsor: Actavis Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): August 17, 2010
• Last Update Submitted That Met QC Criteria: August 13, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy subjects; Nifedipine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: R05-0100