HealthyPhase 1NCT01286701
Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Under Fed Conditions
A Phase 1 study testing Terbinafine Hydrochloride Tablets, 250 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
Trial summary
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Terbinafine Hydrochloride Tablets, 250 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2002to Mar 2002
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' data base).
- Subjects must meet all of the following criteria in order to be included in the study:
- Subjects will be females and/or males, smokers and/or non-smokers, 18 years of age and older.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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- Positive urine drug screen at screening.
- Positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mm Hg; or heart rate less than 50 bpm) at screening.
- Subjects with BMI ≥ 30.0.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub-investigator, contraindicates the subjects participation in this study.
- History of allergic reactions to terbinafine hydrochloride or other related drugs (e.g.naftifine).
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement)within 7 days prior to administration of study medication, except for topical products without systemic absorption or oral contraceptives.
- Subjects who have a depot injection or an implant of any drug (except for depot injection or implant used as method of contraception) 3 months prior to administration of study medication.
- Subjects with a history of any previous liver disease.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follow:
- less than 300 mL of whole blood within 30 days or
- 300 mL to 500 mL of whole blood within 45 days or
- more than 500 mL of whole blood within 56 days. •Smoking more than 25 cigarettes per day.
- Additional exclusion criteria for females only:
- Breast-feeding subjects.
- Positive urine pregnancy test at screening (performed on all females).
- Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. The acceptable methods of contraception are:
- Condom + spermicide
- Diaphragm + spermicide
- Intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration)
- oral contraceptives (starting at least 4 weeks prior to study drug administration)
- Implant (e.g. Norplant®) (starting at least 4 weeks prior to study drug administration)
- Depot injection of a progestogen drug (e.g. Depo-Provera®) (starting at least 4 weeks prior to study drug administration)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, 2-way Crossover Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg and Lamisil® 250 mg Tablets in Healthy Subjects Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.
Read the detailed description
Randomized, 2-way crossover, bioequivalence study of Terbinafine hydrochloride 250 mg tablets and Lamisil® 250 mg Tablets administered as 1 x 250 mg tablet in healthy subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Terbinafine Hydrochloride Tablets, 250 mg
- Keywords
- Bioequivalence, crossover, Terbinafine hydrochloride, fed
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terbinafine Hydrochloride Tablets, 250 mgDrug
Also called Lamisil® 250 mg Tablets
Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine Hydrochloride | Experimental | Terbinafine Hydrochloride Tablets, 250 mg of Dr.Reddy's Laboratories Limited Receives: Drug: Terbinafine Hydrochloride Tablets, 250 mg |
| Lamisil® 250 mg Tablets | Active comparator | Lamisil® 250 mg Tablets of Novartis Receives: Drug: Terbinafine Hydrochloride Tablets, 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence study based on Cmax parameter
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2002
- Primary completionFeb 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Bicrell, Principal investigator, Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286701
- Sponsor's protocol ID
- 01362
- Status last verified
- Jan 2011
- First submitted
- 26 Jan 2011
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, 2-way Crossover Bioequivalence Study of Terbinafine Hydrochloride Tablets, 250 mg and Lamisil® 250 mg Tablets in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01286701
- Acronym / sponsor ID
- 01362
- Conditions
- Healthy
- Keywords
- Bioequivalence, crossover, Terbinafine hydrochloride, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Feb 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 31 Jan 2011 (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 purpose of this study is to compare the rate and extent of absorption of terbinafine hydrochloride 250 mg tablets versus Lamisil® 250 mg tablets administered as 1 x 250 mg tablet under fed conditions.
Detailed description
Randomized, 2-way crossover, bioequivalence study of Terbinafine hydrochloride 250 mg tablets and Lamisil® 250 mg Tablets administered as 1 x 250 mg tablet in healthy subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine Hydrochloride | Experimental | Drug: Terbinafine Hydrochloride Tablets, 250 mgTerbinafine Hydrochloride Tablets, 250 mg of Dr.Reddy's Laboratories Limited |
| Lamisil® 250 mg Tablets | Active comparator | Drug: Terbinafine Hydrochloride Tablets, 250 mgLamisil® 250 mg Tablets of Novartis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Web site, Anapharm volunteers' data base).
- Subjects must meet all of the following criteria in order to be included in the study:
Key exclusion criteria (32 listed)
- Clinically significant illnesses within 4 weeks of the administration of study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical sub-investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 Hydrochloride Tablets, 250 mgAlso: Lamisil® 250 mg TabletsTerbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited. | Drug | Lamisil® 250 mg Tablets, Terbinafine Hydrochloride |
Primary outcome
Bioequivalence study based on Cmax parameter
Time frame: 3 months
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 11 Jan 2012.
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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.
Eric Bicrell principal investigator
Anapharm
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 Hydrochloride Tablets, 250 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in Canada.
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 32 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 11 Jan 2012. 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 Canada. 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?
Bioequivalence study based on Cmax parameter (time frame: 3 months). 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 11 Jan 2012.