Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Alprazolam

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.