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| Sponsor: | Orion Corporation, Orion Pharma |
|---|---|
| Information provided by: | Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT00878865 |
Purpose
The objective of the study is to demonstrate the bioequivalence (BE) of two alprazolam 1 mg tablets.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Alprazolam |
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; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects |
| Enrollment: | 18 |
| Study Start Date: | April 2009 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alprazolam 1 mg tablet
Alprazolam 1 mg tablet
|
Drug: Alprazolam
1 mg tablet one oral dose
|
|
Active Comparator: Xanax 1 mg tablet
Xanax 1 mg tablet
|
Drug: Alprazolam
1 mg tablet
Other Name: Xanax
|
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| 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: | MD, PH.D. Kimmo Ingman, Orion Corporation, Orion Pharma |
| ClinicalTrials.gov Identifier: | NCT00878865 History of Changes |
| Other Study ID Numbers: | 0228014 |
| Study First Received: | April 8, 2009 |
| Last Updated: | November 23, 2009 |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
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Alprazolam bioequivalence |
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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 |