To Determine the Bioequivalence Under Fasting ConditionsPhase 1NCT00652886
Bioavailability Study of Oxandrolone Tablets Under Fasting Conditions
A Phase 1 study testing Oxandrolone and Oxandrin in people with To Determine the Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, Inc. at 1 site in United States.
Trial summary
-To compare the single dose bioavailability of Kali and BTG Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine the Bioequivalence Under Fasting Conditions
- What is being tested?
- Oxandrolone and Oxandrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jun 2005
- 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
- Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
- Each subject shall be given a general physical examination within 28days of the initiation study.
- At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Each female subject will be given a serum test as part of the pregnancy study screening process.
- Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen
Who cannot join
- Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
- Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
- Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
- Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
- Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
- Female subjects who are not able to bear children will not be allowed to participate.
- Female subjects with positive or inconclusive results will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research, Inc
Saint Charles, Missouri, 63301
About this study
Official title: Compare the Relative Bioavailability of Oxandrolone 10mg Tablets With That of OXANDRIN 10 mg Tablets Following a Single Oral Dose(1*10 mg Tablet) in Healthy, Adult Subjects Under Fasting Conditions.
-To compare the single dose bioavailability of Kali and BTG
Read the detailed description
-To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.
- Being tested
- Oxandrolone, Oxandrin
- Keywords
- Bioequivalence, Oxandrolone,fasting
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandroloneDrug
Also called Oxandrin
Tablets, 10mg, single-dose
OxandrinDrug
Also called Oxandrolone
tablets, 10mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received Kali's products under fasting conditions Receives: Drug: Oxandrolone |
| B | Active comparator | Subjects received BTG products under fasting conditions Receives: Drug: Oxandrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startMar 2005
- Primary completionMar 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Determine the Bioequivalence Under Fasting ConditionsStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Investigators
- Steve Herrmann, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652886
- Sponsor's protocol ID
- B053205
- Status last verified
- Apr 2008
- First submitted
- 1 Apr 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compare the Relative Bioavailability of Oxandrolone 10mg Tablets With That of OXANDRIN 10 mg Tablets Following a Single Oral Dose(1*10 mg Tablet) in Healthy, Adult Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT00652886
- Acronym / sponsor ID
- B053205
- Keywords
- Bioequivalence, Oxandrolone,fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cetero Research, San Antonio
- Study start
- Mar 2005
- Primary completion
- Mar 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 4 Apr 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 compare the single dose bioavailability of Kali and BTG
Detailed description
-To compare the bioavailability of Oxandrolone 10mg tablets with that of OXANDRIN 10mg tablets following a single -dose in healthy, adult subjects under fasting conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: OxandroloneSubjects received Kali's products under fasting conditions |
| B | Active comparator | Drug: OxandrinSubjects received BTG products under fasting conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subject at least 18 years of age, may be male or they may be female who are unable to bear children.
- Each subject shall be given a general physical examination within 28days of the initiation study.
- At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Each female subject will be given a serum test as part of the pregnancy study screening process.
- Clinical laboratory measurements will include Hematology, Clinical Chemistry, Urine Analysis, HIV Screen,hepatitis-B, C screen and Drugs of abuse Screen
Key exclusion criteria (7 listed)
- Subjects with a history of alcoholism or drug addiction(during past 2 years), or serious gastrointestinal, renal hepatic or cardiovascular disease, tuberculosis, epilepsy. asthma, diabetes, psychosis or glaucoma will not be eligible for thsi study.
- Subjects with any history of breast or prostate cancer will not be eligible to participate in this study.
- Subjects who have a history of allergic response to the class of drug being tested will be excluded from the study.
- Subjects found to have urine/saliva concentration of any of the tested drugs will not be allowed to participate.
- Subjects who have taken any investigational drug within thirty days prior to the first dosing of the study will not be allowed to participate.
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 |
|---|---|---|
| OxandroloneAlso: OxandrinTablets, 10mg, single-dose | Drug | A |
| OxandrinAlso: Oxandrolonetablets, 10mg, single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 hours
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 4 Apr 2008.
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.
Steve Herrmann principal investigator
Cetero Research, San Antonio
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 Oxandrolone and Oxandrin in people with To Determine the Bioequivalence Under Fasting Conditions, run by Par Pharmaceutical, 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 5 inclusion and 7 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 4 Apr 2008. 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: 24 hours). 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 4 Apr 2008.