Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00979537
First received: September 17, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

The objective of this study was to investigate the bioequivalence of nisoldipine extended-release 40 mg tablets (by Mylan Pharmaceuticals Inc.) with Sular® Extended-Release 40 mg tablet (manufactured for First Horizon) following a single, oral 40 mg (1 × 40 mg tablet) dose administration in healthy adult subjects under fed conditions.


Condition Intervention Phase
Healthy
Drug: Nisoldipine Extended-release Tablets, 40 mg
Drug: Sular Tablets, 40 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Fed Bioequivalence Study of Nisoldipine Extended-Release Tablets (40 mg; Mylan) and Sular® Extended-Release Tablets (40 mg; First Horizon) in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: March 2007
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test: Nisoldipine ER Tablets, 40 mg
Nisoldipine Extended-release Tablets, 40 mg
Drug: Nisoldipine Extended-release Tablets, 40 mg
Active Comparator: Reference: Sular Tablets 40 mg
Sular Tablets, 40 mg
Drug: Sular Tablets, 40 mg

  Eligibility

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

Inclusion Criteria:

  • Age: 18 years and older.
  • Sex: Male and/or non-pregnant, non-lactating female.

    • Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing for each study period. An additional serum (β-HCG) pregnancy test will be performed upon completion of the study.
    • Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapies are permitted in this study. Acceptable forms of contraception include the following:

      1. Intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
      2. Barrier methods containing or used in conjunction with a spermicidal agent, or
      3. Surgical sterilization
    • Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:

      1. Postmenopausal with an absence of menses for at least one (1) year, or
      2. Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
      3. Total hysterectomy
    • During the course of the study, from study screen until study exit - including the washout period, all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.
  • Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women with all subjects having a Body Mass Index (BMI) less than or equal to 30 but greater than or equal to 19.
  • All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, Hepatitis B and Hepatitis C tests, HIV test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 21 days of the initial dose of study medication

Exclusion Criteria:

  • Institutionalized subjects will not be used.
  • Social Habits:

    • Use of any tobacco-containing products within 1 year of the start of the study.
    • Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    • Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication.
    • Any recent, significant change in dietary or exercise habits.
    • A positive test for any drug included in the urine drug screen.
    • History of drug and/or alcohol abuse.
  • Medications:

    • Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial dose of study medication.
    • Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing.
    • Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
  • Diseases:

    • History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.
    • Acute illness at the time of either the pre-study medical evaluation or dosing.
    • A positive HIV, hepatitis B, or hepatitis C test.
  • Abnormal and clinically significant laboratory test results:

    • Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
    • Abnormal and clinically relevant ECG tracing.
  • Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
  • Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
  • Allergy or hypersensitivity to nisoldipine, any of the inactive ingredients, or other calcium channel blocker products.
  • History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
  • Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
  • Average sitting pulse rate less than 55 beats per minute after a five minute rest at screening OR prior to Period I Day 1 dosing. Pulse rate measurements will be taken in triplicate with at least two (2) minutes elapsing in-between measurements.
  • Average sitting systolic blood pressure less than 90 mmHg or average sitting diastolic blood pressure less than 60 mmHg following a five (5) minute rest at screening OR prior to Period I Day 1 dosing. Blood pressure measurements will be taken in triplicate with at least two (2) minutes elapsing in-between readings.
  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: NCT00979537

Locations
United States, North Dakota
Pracs Institute, Ltd
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Mylan Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne Talton, Vice President, Regulatory Affairs, Mylan Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00979537     History of Changes
Other Study ID Numbers: NISO-0702
Study First Received: September 17, 2009
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014