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Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00878514
First received: April 8, 2009
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.


Condition Intervention Phase
Healthy
Drug: Alprazolam
Drug: Xanax
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Cmax, AUCt and AUC∞ [ Time Frame: 48 hours per period ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  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: NCT00878514

Locations
Finland
Orion Pharma Phase I unit
Espoo, Finland, 02101
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Aila Holopainen, M.Sc. Orion Corporation, Orion Pharma
  More Information

No publications provided

Responsible Party: MD, PH.D. Kimmo Ingman, Orion Corporation, orion Pharma
ClinicalTrials.gov Identifier: NCT00878514     History of Changes
Other Study ID Numbers: 0228015
Study First Received: April 8, 2009
Last Updated: November 23, 2009
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Orion Corporation, Orion Pharma:
Alprazolam
Bioequivalence

Additional relevant MeSH terms:
Alprazolam
Anti-Anxiety Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014