Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

This is an interventional basic science trial for Healthy focused on measuring Alprazolam, Bioequivalence Read More

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.