Overview

Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg tablets.
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

- 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.