- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878865
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets
November 23, 2009 updated by: Orion Corporation, Orion Pharma
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects
The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg tablets.
Study Overview
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 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.
The study treatments will be administered after an overnight fast (at least 10 h).
Blood samples will be drawn during both treatment periods.
The planned duration of the study per subject will be 4-5 weeks including a screening visit, 2 treatment periods with a wash-out between the study treatment administrations and a post-treatment period.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Espoo, Finland, 02101
- Orion Pharma Phase I Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alprazolam 1 mg tablet
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1 mg tablet one oral dose
1 mg tablet
Other Names:
|
Active Comparator: Xanax 1 mg tablet
|
1 mg tablet one oral dose
1 mg tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cmax, AUCt and AUC∞
Time Frame: 48 hours per period
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48 hours per period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aila Holopainen, M. Sc., Orion Corporation, OrionPharma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
April 8, 2009
First Submitted That Met QC Criteria
April 8, 2009
First Posted (Estimate)
April 9, 2009
Study Record Updates
Last Update Posted (Estimate)
November 25, 2009
Last Update Submitted That Met QC Criteria
November 23, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0228014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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