We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00878514
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE April 8, 2009
First Posted Date  ICMJE April 9, 2009
Last Update Posted Date November 25, 2009
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2009)
Cmax, AUCt and AUC∞ [ Time Frame: 48 hours per period ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Official Title  ICMJE Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects
Brief Summary The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
Detailed Description

The study is a phase I, open, randomised, crossover, single dose pharmacokinetic study performed in a single centre. The study consists of 2 treatment periods, during which the study subjects will receive the test product and the reference product in a randomised order. During both treatment periods, the study subjects will receive 1 mg of alprazolam as a single oral dose administered after a high-calorie, high-fat meal. Following an overnight fast of at least 10 hours, the study subjects will eat the standardised meal 30 minutes prior to administration of the study treatments. Blood samples will be drawn during both treatment periods.

The duration of the study per subject will be approximately 5 weeks and at most 9 weeks including a screening visit, 2 treatment periods with a wash-out between the study treatment administrations and a post-treatment period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Alprazolam
    Alprazolam 1 mg tablet
  • Drug: Xanax
    Xanax 1 mg tablet
Study Arms  ICMJE
  • Experimental: Alprazolam
    Alprazolam 1 mg tablet
    Intervention: Drug: Alprazolam
  • Active Comparator: Xanax
    Xanax 1 mg tablet
    Intervention: Drug: Xanax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 8, 2009)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent (IC) obtained
  • Good general health ascertained by detailed medical history, and laboratory and physical examinations
  • Finnish speaking males and females, 18-55 (inclusive) years of age
  • Normal body weight defined as body mass index > 19 and < 30 kg/m2 (BMI = weight/height2)
  • Weight at least 50 kg
  • Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems)

Exclusion Criteria:

  • Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease
  • Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
  • Intake of any medication that could affect the outcome of the study. As an exception, contraceptives intra uterine device (IUD) containing levonorgestrel and hormonal implant are allowed.
  • Any clinically significant abnormal laboratory value or physical finding (including electrocardiogram [ECG] and vital signs) that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study, as judged by the investigator.
  • Known hypersensitivity to the active substance(s) or to any of the excipients of the drug
  • History of vasovagal collapses
  • History of anaphylactic/anaphylactoid reactions
  • History of seizures including febrile seizures
  • Pregnant or lactating females
  • Females of childbearing potential if they are not using proper contraception (IUD, hormonal implant or surgical sterilization, spermicidal foam in conjunction with condom on male partner) (Note: women of childbearing potential with no current sexual relationship can be included without contraception according to the judgement of the investigator).
  • Recent or current (suspected) drug abuse or positive result in the drugs abuse test
  • Recent or current alcohol abuse (regular drinking more than 21 units per week for males and more than 16 units per week for females [1 unit = 4 cl spirits or equivalent])
  • Current use of nicotine containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine containing products during the study (from the screening visit to the end-of-study visit).
  • Use of caffeine containing beverages more than 600 mg of caffeine/day and/or inability to refrain from the use of caffeine containing beverages during the treatment periods until 24 h after study treatment administration.
  • Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
  • Administration of another investigational treatment within 90 days prior to the first study treatment administration
  • Unsuitable veins for repeated venipuncture or for cannulation
  • Predictable poor compliance or inability to communicate well with the study centre personnel
  • Inability to participate in all treatment periods.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00878514
Other Study ID Numbers  ICMJE 0228015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MD, PH.D. Kimmo Ingman, Orion Corporation, orion Pharma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aila Holopainen, M.Sc. Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP