PharmacokineticsPhase 1NCT00810316
Evaluate Pharmacokinetics Of Two Different Pharmaceutical Oral Formulations Of Alprazolam And A Clonazepam Tablet In Mexican Healthy Population
A Phase 1 study testing Alprazolam, Alprazolam XR and Clonazepam in people with Pharmacokinetics, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Mexico.
Trial summary
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Alprazolam, Alprazolam XR and Clonazepam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2008to Nov 2008
- 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
- Healthy male or female volunteers aged between 18 and 40 years old.
Who cannot join
- Subjects presenting changes on their vital signs constants registered at volunteers' screening.
- Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Pfizer Investigational Site
Col. Arenal Tepepan, Mexico City, 14610
About this study
Official title: Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
Read the detailed description
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
- Conditions
- Pharmacokinetics
- Being tested
- Alprazolam, Alprazolam XR, Clonazepam
- Keywords
- Alprazolam, Alprazolam extended release, Clonazepam, Pharmacokinetics, Mexican population, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called Tafil, Xanax
Administration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
Alprazolam XRDrug
Also called Tafil AP, Xanax XR
Administration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
ClonazepamDrug
Also called Rivotril
Administration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Other | Not described Receives: Drug: Alprazolam |
| Treatment B | Other | Not described Receives: Drug: Alprazolam XR |
| Treatment C | Other | Not described Receives: Drug: Clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
Measured: Sampling times: 0 to 96 hours
AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.
Measured: Sampling times: 0 to 96 hours
Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.
Measured: Sampling times: 0 to 96 hours
t 1/2: Half life time.
Measured: Sampling times: 0 to 96 hours
Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile.
Measured: Sampling times: 0 to 96 hours
Secondary outcomes (1)
No Secondary Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810316
- Sponsor's protocol ID
- A6131015
- Status last verified
- Jan 2021
- First submitted
- 16 Dec 2008
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate The Pharmacokinetics Of Two Alprazolam Formulations (Immediate Release And Extended Release Tablets) And A Clonazepam Tablet In A Healthy Mexican Population
- ClinicalTrials.gov ID
- NCT00810316
- Acronym / sponsor ID
- A6131015
- Conditions
- Pharmacokinetics
- Keywords
- Alprazolam, Alprazolam extended release, Clonazepam, Pharmacokinetics, Mexican population, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Dec 2008 (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.
To estimate the pharmacokinetics of single doses of benzodiazepines in Mexican adult healthy volunteers: a) alprazolam tablet extended release, b) alprazolam tablet immediate release, and clonazepam tablet.
Detailed description
To determine pharmacokinetics of alprazolam and clonazepam in Latin-American population; in Mexico, both drugs are still widely used as first or second choice in the treatment of anxiety disorders.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Other | Drug: Alprazolam |
| Treatment B | Other | Drug: Alprazolam XR |
| Treatment C | Other | Drug: Clonazepam |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female volunteers aged between 18 and 40 years old.
Key exclusion criteria (2 listed)
- Subjects presenting changes on their vital signs constants registered at volunteers' screening.
- Volunteers with any of the following: noncompliance of proposed inclusion criteria; requiring another drug product throughout the study conduction; pregnant or nursing females; history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal, neurological, endocrine, psychiatric, hematopoietic or any other anemia kind, disease, asthma, or organic disorder; history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer or any condition possibly affecting drug absorption; history of acute narrow or glaucoma; exposed to drug products known as hepatic enzyme or inductors; who had received any drug product within 14 days or 5 half lives; who had been hospitalized due to any problem within 60 days prior to study start; history of sensitivity to BZD; who had drink alcohol or any beverage containing xanthines or who had taken smoked food or grapefruit juice within 72 hours prior to start hospitalization period, who had blood donated or lost 450 mL or more within 60 days prior to study start; requiring any special diet regardless the cause.
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 |
|---|---|---|
| AlprazolamAlso: Tafil, XanaxAdministration of a single oral dose tablet of 1 mg of alprazolam immediate release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions | Drug | Treatment A |
| Alprazolam XRAlso: Tafil AP, Xanax XRAdministration of a single oral dose tablet of 1 mg of alprazolam modified release on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions | Drug | Treatment B |
| ClonazepamAlso: RivotrilAdministration of a single oral dose of two tablets of 0.5 mg of clonazepam on Day 1 morning, between 8-9 am with 250 ml of water in at least 10 hours of fasting conditions | Drug | Treatment C |
Primary outcome
AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method.
Time frame: Sampling times: 0 to 96 hours
AUC inf: Area under the curve of plasma concentration from administration up to infinitum extrapolated time.
Time frame: Sampling times: 0 to 96 hours
Cmax: Maximum plasma concentration graphically obtained, based on plasma concentration versus time profile.
Time frame: Sampling times: 0 to 96 hours
t 1/2: Half life time.
Time frame: Sampling times: 0 to 96 hours
Tmax: Time from administration up to maximum plasma concentration, graphically obtained based on plasma concentration versus time profile.
Time frame: Sampling times: 0 to 96 hours
1 secondary outcome
No Secondary Outcomes
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 28 Jan 2021.
- To obtain contact information for a study center near you, click here.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.
Pfizer CT.gov Call Center study director
Pfizer
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, Alprazolam XR and Clonazepam in people with Pharmacokinetics, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Mexico.
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 1 inclusion and 2 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 28 Jan 2021. 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 Mexico. 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?
AUC last: Area under the curve of plasma concentration from administration up to time t (last sampling timepoint) calculated by trapezoid method. (time frame: Sampling times: 0 to 96 hours). The study lists 5 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 28 Jan 2021.