HealthyPhase 1NCT00878514
Bioequivalence Study Comparing Two Alprazolam 1 mg Tablets Under Fed Conditions
A Phase 1 study testing Alprazolam and Xanax in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Alprazolam and Xanax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- May 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
Read the 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.
- Conditions
- Healthy
- Being tested
- Alprazolam, Xanax
- Keywords
- Alprazolam, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Alprazolam 1 mg tablet
XanaxDrug
Xanax 1 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam | Experimental | Alprazolam 1 mg tablet Receives: Drug: Alprazolam |
| Xanax | Active comparator | Xanax 1 mg tablet Receives: Drug: Xanax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUCt and AUC∞
Measured: 48 hours per period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Aila Holopainen, M.Sc., Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878514
- Sponsor's protocol ID
- 0228015
- Status last verified
- Nov 2009
- First submitted
- 8 Apr 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00878514
- Acronym / sponsor ID
- 0228015
- Conditions
- Healthy
- Keywords
- Alprazolam, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to demonstrate the bioequivalence (BE) of alprazolam 1 mg tablet with Xanax® 1 mg tablet under fed conditions.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alprazolam | Experimental | Drug: AlprazolamAlprazolam 1 mg tablet |
| Xanax | Active comparator | Drug: XanaxXanax 1 mg tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprazolamAlprazolam 1 mg tablet | Drug | Alprazolam |
| XanaxXanax 1 mg tablet | Drug | Xanax |
Primary outcome
Cmax, AUCt and AUC∞
Time frame: 48 hours per period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aila Holopainen, M.Sc. study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprazolam and Xanax in people with Healthy, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax, AUCt and AUC∞ (time frame: 48 hours per period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.