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History of Changes for Study: NCT00878514
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Latest version (submitted November 23, 2009) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 8, 2009 None (earliest Version on record)
2 November 23, 2009 Recruitment Status, Study Status and Contacts/Locations
Comparison Format:

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Study NCT00878514
Submitted Date:  April 8, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: 0228015
Brief Title: Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2009
Overall Status: Not yet recruiting
Study Start: May 2009
Primary Completion: July 2009 [Anticipated]
Study Completion: July 2009 [Anticipated]
First Submitted: April 8, 2009
First Submitted that
Met QC Criteria:
April 8, 2009
First Posted: April 9, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 8, 2009
Last Update Posted: April 9, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Orion Corporation, Orion Pharma
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Healthy
Keywords: Alprazolam
Bioequivalence
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Phase 1
Interventional Study Model: Crossover Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 18 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Alprazolam
Alprazolam 1 mg tablet
Drug: Alprazolam
Alprazolam 1 mg tablet
Active Comparator: Xanax
Xanax 1 mg tablet
Drug: Xanax
Xanax 1 mg tablet
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cmax, AUCt and AUC∞
[ Time Frame: 48 hours per period ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Aila Holopainen, M. Sc.
Telephone: +358 (0)10 4261
Email: aila.holopainen@orionpharma.com
Central Contact Backup: Kimmo Ingman, MD, Ph.D.
Telephone: +358 (0)10 4261
Email: kimmo.ingman@orionpharma.com
Study Officials: Aila Holopainen, M.Sc.
Study Director
Orion Corporation, Orion Pharma
Locations: Finland
Orion Pharma Phase I unit
Espoo, Finland, 02101
Contact:Contact: Kimmo Ingman, MD, Ph.D. +358 (0)10 4261 kimmo.ingman@orionpharma.com
Contact:Principal Investigator: Kimmo Ingman, MD, Ph.D.
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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