HealthyPhase 1NCT00833586
Terbinafine HCl 250 mg Tablet Under Fasting Conditions
A Phase 1 study testing Terbinafine HCl 250mg tablets and Lamisil® 250 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects. 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?
- Terbinafine HCl 250mg tablets and Lamisil® 250 mg Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jan 2002
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations
- If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
Who cannot join
- If female, pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction.
- Presence of gastrointestinal disease ot history of malabsorption within the last year.
- History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
- Presence of a medical condition requiring regular treatment with prescription drugs.
Show all 13Show fewer
- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes. within 30 days prior to dosing.
- Receipt of any drug as part of a research study within 30 days prior to dosing.
- Drug or alcohol addition requiring treatment in the past 12 months.
- Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
- Positive test results for drug of abuse at screening.
- Tobacco user within 90 days of the first study dose.
- Unable, or unwilling to tolerate multiple venipunctures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novum Pharmaceutical Research Services
Pittsburgh, Pennsylvania, 15206-3817
About this study
Official title: The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.
Read the detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
- Conditions
- Healthy
- Being tested
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Keywords
- Bioequivalence, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine HCl 250mg tabletsDrug
1 x 250 mg
Lamisil® 250 mg TabletsDrug
1 x 250 mg
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine | Experimental | Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period Receives: Drug: Terbinafine HCl 250mg tablets |
| Lamisil® | Active comparator | Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period Receives: Drug: Lamisil® 250 mg Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Bioequivalence based on Cmax
Measured: Blood samples collected over 144 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 144 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 144 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJan 2002
- Primary completionJan 2002
- Study completionJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shirley Ann Kennedy, M.D., Principal investigator, Novum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833586
- Sponsor's protocol ID
- 10136024
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2009
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relative Bioavailability of Two Terbinafine HCl 250 mg Tablet Formulations Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00833586
- Acronym / sponsor ID
- 10136024
- Conditions
- Healthy
- Keywords
- Bioequivalence, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Jan 2002 (actual)
- Study completion
- Jan 2002 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Posted 18 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under fasted conditions in healthy, non-tobacco using male and female adult subjects.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine | Experimental | Drug: Terbinafine HCl 250mg tabletsTerbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period |
| Lamisil® | Active comparator | Drug: Lamisil® 250 mg TabletsLamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females, 18 years or older inclusive with a body mass index (BMI) of 30 or less.
- Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
- Signed and dated informed consent form, which meets all criteria of current FDA regulations
- If female and of child bearing potential subjects must be prepared to abstain from sexual intercourse or use a reliable barrier method of contraception (e.g. condom, IUD) during the duration of the study. Female subjects who have used oral contraceptives within 14 days or injected hormonal contraceptives within 180 days of dosing will not be allowed to participate.
Key exclusion criteria (13 listed)
- If female, pregnant, lactating or likely to become pregnant during the study.
- History of allergy or sensitivity to terbinafine, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
- Significant history or current evidence of chronic evidence of chronic infectious disease, system disorder ot organ dysfunction.
- Presence of gastrointestinal disease ot history of malabsorption within the last year.
- History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
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 |
|---|---|---|
| Terbinafine HCl 250mg tablets1 x 250 mg | Drug | Terbinafine |
| Lamisil® 250 mg Tablets1 x 250 mg | Drug | Lamisil® |
Primary outcome
Cmax - Maximum Observed Concentration - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Terbinafine in Plasma
Time frame: Blood samples collected over 144 hour period
Bioequivalence based on AUC0-t
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shirley Ann Kennedy, M.D. principal investigator
Novum
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 Terbinafine HCl 250mg tablets and Lamisil® 250 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA 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 4 inclusion and 13 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 19 Aug 2024. 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?
Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax - Maximum Observed Concentration - Terbinafine in Plasma (time frame: Blood samples collected over 144 hour period). The study lists 3 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 19 Aug 2024.