Anxiety DisordersPhase 1NCT01745575
Bioequivalence Trial of Alprazolam 2 mg Tablets
A Phase 1 study testing Alprazolam 2mg tablets and Alprazolam 2 mg tablets in people with Anxiety Disorders, run by GlaxoSmithKline.
Trial summary
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg (Pharmacia \& Upjohn). One tablet was the single dosage. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Alprazolam 2mg tablets and Alprazolam 2 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 28 Mar 2010to 5 Apr 2010
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
- Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
- Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -
Who cannot join
- Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
- Requirement of any kind of medication during the course of the study, except study medication.
- History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
- Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
- Hospitalization for any cause in the seven months before the beginning of the study.
- Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice one week study beginning up to the las blood sample.
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- Blood donation or loss => 450 ml in the 60 days before the beginning of the study.
- History of alcohol abuse. Use of products containing tobacco, or excess of nicotine, equivalent to five cigarettes per day.
- Positive pregnancy test or breast-feeidg. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Female volunteers on oral contraceptives.
- -
About this study
Official title: Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Trial With Single Dosageof Two Oral Preparations Containing 2 mg of Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. vs. Tafil 2.0 mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.
Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg (Pharmacia \& Upjohn). One tablet was the single dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 26 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
- Conditions
- Anxiety Disorders
- Being tested
- Alprazolam 2mg tablets, Alprazolam 2 mg tablets
- Keywords
- Bioequivalence, Alprazolam, Anxiety disorders, Mexico
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam 2mg tabletsDrug
Also called Tafil 2 mg Pharmacia & Upjohn SA de CV
Reference product
Alprazolam 2 mg tabletsDrug
Also called Zamoprax 2 mg GlaxoSmithKline Mexico SA de CV
Test product
| Study group | Role | What they receive |
|---|---|---|
| A(reference)/B(test) | Experimental | initial administration of reference and cross-over to test Receives: Drug: Alprazolam 2mg tablets; Drug: Alprazolam 2 mg tablets |
| B(test)/A(reference) | Experimental | initial administration of test and cross-over to reference Receives: Drug: Alprazolam 2mg tablets; Drug: Alprazolam 2 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (CMAX) of alprazolam
Pharmacokinetics
Measured: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage
Area under the plasma concentration versus time curve (AUC) of alprazolam
Pharmacokinetics
Measured: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study start28 Mar 2010
- Primary completion5 Apr 2010
- Study completion5 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745575
- Sponsor's protocol ID
- 116981
- Status last verified
- Jun 2017
- First submitted
- 6 Dec 2012
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Trial With Single Dosageof Two Oral Preparations Containing 2 mg of Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. vs. Tafil 2.0 mg, Pharmacia &Upjohn, S.A. de C.V.) in Fasting Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01745575
- Acronym / sponsor ID
- 116981
- Conditions
- Anxiety Disorders
- Keywords
- Bioequivalence, Alprazolam, Anxiety disorders, Mexico
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2010 (actual)
- Primary completion
- 5 Apr 2010 (actual)
- Study completion
- 5 Apr 2010 (actual)
- First posted
- 10 Dec 2012 (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 this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.
Test product was Zamoprax® 2 mg (GlaxoSmithKline) and reference product Tafil® 2 mg (Pharmacia \& Upjohn). One tablet was the single dosage.
The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.
The population was composed of 26 healthy volunteers, both genders, adults between 18-50 years.
The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(reference)/B(test) | Experimental | Drug: Alprazolam 2mg tablets, Drug: Alprazolam 2 mg tabletsinitial administration of reference and cross-over to test |
| B(test)/A(reference) | Experimental | Drug: Alprazolam 2mg tablets, Drug: Alprazolam 2 mg tabletsinitial administration of test and cross-over to reference |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
- Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.
- Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -
Key exclusion criteria (10 listed)
- Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.
- Requirement of any kind of medication during the course of the study, except study medication.
- History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.
- Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
- Hospitalization for any cause in the seven months before the beginning of the study.
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 2mg tabletsAlso: Tafil 2 mg Pharmacia & Upjohn SA de CVReference product | Drug | A(reference)/B(test), B(test)/A(reference) |
| Alprazolam 2 mg tabletsAlso: Zamoprax 2 mg GlaxoSmithKline Mexico SA de CVTest product | Drug | A(reference)/B(test), B(test)/A(reference) |
Primary outcome
Peak Plasma Concentration (CMAX) of alprazolam
Time frame: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage
Pharmacokinetics
Area under the plasma concentration versus time curve (AUC) of alprazolam
Time frame: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage
Pharmacokinetics
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 20 Jun 2017.
- Results for study 116981 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alprazolam 2mg tablets and Alprazolam 2 mg tablets in people with Anxiety Disorders, run by GlaxoSmithKline.
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 3 inclusion and 10 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Peak Plasma Concentration (CMAX) of alprazolam (time frame: 0.0, 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 6.0, 9.0, 12.0, 18.0, 22.0, 36.0, 48.0,and 60.0 hours postdosage). The study lists 2 primary outcomes in all. 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 20 Jun 2017.