Status:
COMPLETED
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00878514
Start Date
May 1 2009
End Date
July 1 2009
Last Update
November 25 2009
Active Locations (1)
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1
Orion Pharma Phase I unit
Espoo, Finland, 02101