Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets
Information source: Orion Corporation, Orion Pharma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Alprazolam (Drug); Alprazolam (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Orion Corporation, Orion Pharma Official(s) and/or principal investigator(s):
Aila Holopainen, M. Sc., Study Director, Affiliation: Orion Corporation, OrionPharma
Overall contact:
Aila Holopainen, M.Sc., Phone: +358 (0)10 4261, Email: aila.holopainen@orionpharma.com
Summary
The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg
tablets.
Clinical Details
Official title: Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects
Study design: Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Cmax, AUCt and AUC∞
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Aila Holopainen, M.Sc., Phone: +358 (0)10 4261, Email: aila.holopainen@orionpharma.com
Orion Pharma phase I unit, Espoo 02101, Finland
Additional Information
Starting date: April 2009
Ending date: July 2009
Last updated: April 8, 2009
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