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| 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: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
| 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 |
| 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 |
|---|---|
|
Alprazolam: Experimental
Alprazolam 1 mg tablet
|
Drug: Alprazolam
Alprazolam 1 mg tablet
|
|
Xanax: Active Comparator
Xanax 1 mg tablet
|
Drug: Xanax
Xanax 1 mg tablet
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Orion Corporation, orion Pharma ( MD, PH.D. Kimmo Ingman ) |
| Study ID Numbers: | 0228015 |
| Study First Received: | April 8, 2009 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00878514 History of Changes |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
|
Alprazolam Bioequivalence |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Pharmacologic Actions Alprazolam Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Central Nervous System Agents |