Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg
 tablet with Xanax® 1 mg tablet under fed conditions.
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.
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.