Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions

NCT00878514 | Completed Phase 1

• 1 other identifier: 0228015
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Alprazolam; Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Cmax, AUCt and AUC∞

  48 hours per period

Study Arms (2)

Alprazolam

EXPERIMENTAL

Alprazolam 1 mg tablet

Drug: Alprazolam

Xanax

ACTIVE COMPARATOR

Xanax 1 mg tablet

Drug: Xanax

Interventions

Alprazolam DRUG

Alprazolam 1 mg tablet

Alprazolam

Xanax DRUG

Xanax 1 mg tablet

Xanax

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Orion Pharma Phase I unit

Espoo, 02101, Finland

Location

MeSH Terms

Interventions

Alprazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Aila Holopainen, M.Sc.

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: November 25, 2009

Record last verified: 2009-11

Locations

FI (1)