A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Non-fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Actavis Inc.
ClinicalTrials.gov Identifier:
NCT00865384
First received: March 17, 2009
Last updated: August 13, 2010
Last verified: August 2010
  Purpose

The purpose of this study is to compare the relative bioavailability of 15 mg Mirtazapine Tablets by Purepac Pharmaceutical Co with that of 15 mg REMERON® Tablets by Organon Inc. following a single oral dose (1 x 15 mg) in healthy adult volunteers under non-fasting conditions.


Condition Intervention Phase
Healthy
Drug: Mirtazapine 15 mg tablets, single dose
Drug: REMERON® 15 mg tablets, single dose
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 15 mg Mirtazapine 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: 120 hours ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2001
Study Completion Date: September 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Mirtazapine 15 mg tablets, single dose
Drug: Mirtazapine 15 mg tablets, single dose
A: Experimental Subjects received Purepac formulated products under non-fasting conditions
Active Comparator: B
REMERON® 15 mg tablets, single dose
Drug: REMERON® 15 mg tablets, single dose
B: Active comparator Subjects received Organon Inc. formulated products under non-fasting conditions
Other Name: Mirtazapine

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 15 mg Mirtazapine 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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Screening Demographics: All volunteers selected for this study will be healthy men and women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Men -1983 Metropolitan Height and Weight Table or as per Desirable Weights for Women - 1983 Metropolitan Height and Weight Table.
  • Screening Procedures: Each volunteer will complete the screening process within 30 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
    • URINE DRUG SCREEN: ethyl alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates and phencyclidine.
    • SERUM PREGNANCY SCREEN (female volunteers only)
  • If female and:

    • of childbearing potential, is practicing an acceptable barrier method of birth control for the duration of the study as judged by the investigator(s), such as condoms, sponge, foams, jellies, diaphragm; 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:

  • Volunteers with a recent history of drug or alcohol addiction or abuse.
  • 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).
  • Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be
  • Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
  • Volunteers demonstrating a positive drug abuse screen when screened for this study.
  • Female volunteers demonstrating a positive pregnancy screen.
  • Female volunteers who are currently breastfeeding.
  • Volunteers with a history of allergic response(s) to mirtazapine or related drugs.
  • Volunteers with a history of clinically significant allergies including drug allergies.
  • Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator).
  • Volunteers who currently use tobacco products.
  • Volunteers who have taken any drug known to induce or inhibit hepatic• drug metabolism in the 30 days prior to Period I dosing.
  • Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
  • 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.
  • Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
  • 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: NCT00865384

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: NCT00865384     History of Changes
Other Study ID Numbers: R00-436
Study First Received: March 17, 2009
Last Updated: August 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Actavis Inc.:
Bioequivalence
Mirtazapine
Healthy subjects

Additional relevant MeSH terms:
Mirtazapine
Mianserin
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on October 16, 2014