AllergyPhase 1NCT00947063
To Demonstrate the Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
A Phase 1 study testing Promethazine HCl 50 mg Tablets (Sandoz, Inc) and Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) in people with Allergy, run by Sandoz.
Trial summary
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergy
- What is being tested?
- Promethazine HCl 50 mg Tablets (Sandoz, Inc) and Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Aug 2004
- 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
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Who cannot join
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
About this study
Official title: A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.
- Conditions
- Allergy
- Being tested
- Promethazine HCl 50 mg Tablets (Sandoz, Inc), Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)
- Keywords
- Antihistamine
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promethazine HCl 50 mg Tablets (Sandoz, Inc)Drug
Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)Drug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Promethazine HCl 50 mg Tablets (Sandoz, Inc) Receives: Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc) |
| 2 | Active comparator | Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) Receives: Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on AUC and Cmax
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2004
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Irwin Plisco, M.D., Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947063
- Sponsor's protocol ID
- B043722
- Status last verified
- Jul 2009
- First submitted
- 24 Jul 2009
- Last updated
- 28 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of Promethazine HCl 50 mg Tablets Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00947063
- Acronym / sponsor ID
- B043722
- Conditions
- Allergy
- Keywords
- Antihistamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 27 Jul 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.
To demonstrate the relative bioavailability study of Promethazine HCl 50 mg tablets under fasting conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Promethazine HCl 50 mg Tablets (Sandoz, Inc)Promethazine HCl 50 mg Tablets (Sandoz, Inc) |
| 2 | Active comparator | Drug: Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories)Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Key exclusion criteria (2 listed)
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
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 |
|---|---|---|
| Promethazine HCl 50 mg Tablets (Sandoz, Inc) | Drug | 1 |
| Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) | Drug | 2 |
Primary outcome
Bioequivalence based on AUC and Cmax
Time frame: 12 days
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 Mar 2017.
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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.
Irwin Plisco, M.D. principal investigator
Cetero Research, San Antonio
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Promethazine HCl 50 mg Tablets (Sandoz, Inc) and Phenergan (Promethazine HCl) 50 mg Tablets (Wyeth Laboratories) in people with Allergy, run by Sandoz.
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 Mar 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?
Bioequivalence based on AUC and Cmax (time frame: 12 days). 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 Mar 2017.