HealthyPhase 1NCT01188031
A Relative Bioavailability Study of 2 mg Alprazolam OD Tablets Under Fasting Conditions
A Phase 1 study testing ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG and NIRAVAM TM 2 mg orally disintegrating tablets, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG and NIRAVAM TM 2 mg orally disintegrating tablets, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jul 2006
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who met the following criteria were included in the study.
- Volunteers who were informed of the nature of the study and who read, reviewed, and signed the informed consent prior to Period I dosing.
- Volunteers who completed the screening process within 28 days prior to Period I dosing.
- Volunteers who were healthy adult men and women 18 years of age or older at the time of dosing.
- Volunteers who had a body mass index (BMI) between 18-32 kg/nr', inclusive, and weighed at least 110 lbs.
- Volunteers who were healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations form the normal range that were considered clinically relevant by the study physician and investigator were evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
- Female volunteers ofpostmenopausal (no menses) status for at least 1 year and has a serum FSH level 2: 30 mlU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.)
Who cannot join
- Subjects who met any ofthe following criteria were excluded from the study.
- Volunteers who reported receiving any investigational drug within 28 days prior to Period I dosing.
- Volunteers who reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Volunteers whose clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed clinically significant.
- Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers who reported a history of allergic response(s) to alprazolam or related drugs.
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- Volunteers who reported the use of any systemic prescription medication in the 14 days prior to Period I dosing.
- Volunteers who reported the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Volunteers who reported a history ofclinically significant allergies including drug allergies.
- Volunteers who reported a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who reported a history of drug or alcohol abuse addiction or abuse within the past year.
- Volunteers who demonstrated a positive drug abuse screen for this study prior to Period I dose administration.
- Volunteers who currently used tobacco products.
- Volunteers who reported donating greater than 150 mL ofblood within 28 days prior to Period I dosing. All subjects were advised not to donate blood for four weeks after completing the study.
- Volunteers who donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects were advised not to donate plasma for four weeks after completing the study
- Volunteers who demonstrated a positive pregnancy screen (females only).
- Volunteers who were currently pregnant or breastfeeding (females only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under fasting conditions.
Read the detailed description
Study Type: Interventional Study Design: This was a single-center, randomized, two-way crossover study conducted under fasting conditions Official Title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, NIRAVAM TM 2 mg orally disintegrating tablets, single dose
- Keywords
- Bioequivalence, ALPRAZOLAM, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MGDrug
Also called NIRAVAM
A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions
NIRAVAM TM 2 mg orally disintegrating tablets, single doseDrug
Also called ALPRAZOLAM
B: Active comparator Subjects received Schwarz Pharma Inc. formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| ALPRAZOLAM ORALLY DISINTEGRATING TABLETS | Experimental | ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, single dose Receives: Drug: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG |
| NIRAVAM TM | Active comparator | NIRAVAM TM 2 mg orally disintegrating tablets, single dose Receives: Drug: NIRAVAM TM 2 mg orally disintegrating tablets, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJun 2006
- Primary completionJul 2006
- Study completionJul 2006
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Carlson,, Pharm.D,, Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188031
- Sponsor's protocol ID
- R06-0302
- Status last verified
- Aug 2010
- First submitted
- 23 Aug 2010
- Last updated
- 25 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01188031
- Acronym / sponsor ID
- R06-0302
- Conditions
- Healthy
- Keywords
- Bioequivalence, ALPRAZOLAM, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 25 Aug 2010 (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.
This study compared the relative bioavailability (rate and extent ofbsorption) of Alprazolam Orally Disintegrating Tablets, 2.0 mg by Purepac Pharmaceutical Co. with that of Niravam' 2 mg Orally Disintegrating Tablets manufactured for Schwarz Pharma, Inc. (by Cima Labs Inc.®)following a single, oral dose (I x 2 mg disintegrating tablet) in healthy adult volunteers administered under fasting conditions.
Detailed description
Study Type: Interventional Study Design: This was a single-center, randomized, two-way crossover study conducted under fasting conditions Official Title: A Relative Bioavailability Study of 2 mg Alprazolam Oral Disintegrating Tablets under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALPRAZOLAM ORALLY DISINTEGRATING TABLETS | Experimental | Drug: ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MGALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG, single dose |
| NIRAVAM TM | Active comparator | Drug: NIRAVAM TM 2 mg orally disintegrating tablets, single doseNIRAVAM TM 2 mg orally disintegrating tablets, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who met the following criteria were included in the study.
- Volunteers who were informed of the nature of the study and who read, reviewed, and signed the informed consent prior to Period I dosing.
- Volunteers who completed the screening process within 28 days prior to Period I dosing.
- Volunteers who were healthy adult men and women 18 years of age or older at the time of dosing.
- Volunteers who had a body mass index (BMI) between 18-32 kg/nr', inclusive, and weighed at least 110 lbs.
Key exclusion criteria (17 listed)
- Subjects who met any ofthe following criteria were excluded from the study.
- Volunteers who reported receiving any investigational drug within 28 days prior to Period I dosing.
- Volunteers who reported any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Volunteers whose clinical laboratory test values outside the accepted reference range and, when confirmed on re-examination, were deemed clinically significant.
- Volunteers who demonstrated a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
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 |
|---|---|---|
| ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MGAlso: NIRAVAMA: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions | Drug | ALPRAZOLAM ORALLY DISINTEGRATING TABLETS |
| NIRAVAM TM 2 mg orally disintegrating tablets, single doseAlso: ALPRAZOLAMB: Active comparator Subjects received Schwarz Pharma Inc. formulated products under fasting conditions | Drug | NIRAVAM TM |
Primary outcome
Rate and Extend of Absorption
Time frame: 72hr
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 Aug 2010.
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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.
James D. Carlson,, Pharm.D, principal investigator
PRACS Institute, Ltd.
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 ORALLY DISINTEGRATING TABLETS, 2.0 MG and NIRAVAM TM 2 mg orally disintegrating tablets, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
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 7 inclusion and 17 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 Aug 2010. 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 United States. 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?
Rate and Extend of Absorption (time frame: 72hr). 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 Aug 2010.