Official Title: “Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects”

The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg tablets.

Study Type: Interventional

Study Design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: June 2009

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. The study treatments will be administered after an overnight fast (at least 10 h). Blood samples will be drawn during both treatment periods. The planned duration of the study per subject will be 4-5 weeks including a screening visit, 2 treatment periods with a wash-out between the study treatment administrations and a post-treatment period.

Intervention(s) in this Clinical Trial

• Drug: Alprazolam
  • 1 mg tablet one oral dose
• Drug: Alprazolam
  • 1 mg tablet

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Alprazolam 1 mg tablet
  • Alprazolam 1 mg tablet
• Active Comparator: Xanax 1 mg tablet
  • Xanax 1 mg tablet

Primary Measures

• Cmax, AUCt and AUC∞
  • Time Frame: 48 hours per period
    Safety Issue?: No

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
• 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
• Predictable poor compliance or inability to communicate well with the study centre personnel
• Inability to participate in all treatment periods.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Orion Corporation, Orion Pharma

Overall Clinical Trial Officials and Contacts

Aila Holopainen, M. Sc. Study Director Orion Corporation, OrionPharma  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00878865

Study ID Number: 0228014

ClinicalTrials.gov Identifier: NCT00878865

Health Authority: Finland: Ministry of Social Affairs and Health