Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions - Full Text View

Sponsor:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00878514

Purpose

The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.

Condition	Intervention	Phase
Healthy	Drug: Alprazolam Drug: Xanax	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Malnutrition

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Cmax, AUCt and AUC∞ [ Time Frame: 48 hours per period ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	May 2009
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Alprazolam Alprazolam 1 mg tablet	Drug: Alprazolam Alprazolam 1 mg tablet
Active Comparator: Xanax Xanax 1 mg tablet	Drug: Xanax Xanax 1 mg tablet

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 administered after a high-calorie, high-fat meal. Following an overnight fast of at least 10 hours, the study subjects will eat the standardised meal 30 minutes prior to administration of the study treatments. Blood samples will be drawn during both treatment periods.

The duration of the study per subject will be approximately 5 weeks and at most 9 weeks including a screening visit, 2 treatment periods with a wash-out between the study treatment administrations and a post-treatment period.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878514

Locations

Finland
Orion Pharma Phase I unit
Espoo, Finland, 02101

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Study Director:

Aila Holopainen, M.Sc.

Orion Corporation, Orion Pharma

More Information

No publications provided

Responsible Party:	MD, PH.D. Kimmo Ingman, Orion Corporation, orion Pharma
ClinicalTrials.gov Identifier:	NCT00878514 History of Changes
Other Study ID Numbers:	0228015
Study First Received:	April 8, 2009
Last Updated:	November 23, 2009
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by Orion Corporation, Orion Pharma:

Alprazolam
Bioequivalence

Additional relevant MeSH terms:

Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012