HealthyPhase 1NCT01513681
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
A Phase 1 study testing Lamotrigine and Lamictal® in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
This is an single dose,two-way, crossover, oral bioequivalence study. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lamotrigine and Lamictal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females at least 18 years of age inclusive
- Informed of the nature of the study and given written informed consent
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.
Who cannot join
- Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion
- Recent history of mental illness, drug addition,drug abuse or alcoholism
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the -counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutics indications as judged by the attending physician.
- Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
- If female, the subjects is lactating or has a positive pregnancy test screening and prior to each of the two treatments periods. Females of child bearing potential must use a medical acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods or contraception that may be used by the subject and/or her partner are; oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, IUD, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.
This is an single dose,two-way, crossover, oral bioequivalence study.
Read the detailed description
The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.
- Conditions
- Healthy
- Being tested
- Lamotrigine, Lamictal®
- Keywords
- Bioequivalence, Lamotrigine, crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal® 200 mg
Lamotrigine Tablets 200 mg
Lamictal®Drug
Lamictal® 200 mg Tablets
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine Tablets 200 mg | Experimental | Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited Receives: Drug: Lamotrigine; Drug: Lamictal® |
| Lamictal® 200 mg Tablets | Active comparator | Lamictal® 200 mg Tablets of GlaxoSmithKline Inc Receives: Drug: Lamotrigine; Drug: Lamictal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC)
Measured: Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startNov 2002
- Primary completionNov 2002
- Study completionNov 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ralph Scallion, MD, Principal investigator, AAI Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513681
- Sponsor's protocol ID
- AAI-US-136
- Status last verified
- Oct 2002
- First submitted
- 17 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose, Two-way, Crossover, Oral Bioequivalence Study of Lamotrigine Tablets 200 mg With Lamictal® Tablets 200 mg in Healthy, Volunteers Under Fed Condition.
- ClinicalTrials.gov ID
- NCT01513681
- Acronym / sponsor ID
- AAI-US-136
- Conditions
- Healthy
- Keywords
- Bioequivalence, Lamotrigine, crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Nov 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 20 Jan 2012 (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.
This is an single dose,two-way, crossover, oral bioequivalence study.
Detailed description
The study was an single dose, two-way, crossover, oral bioequivalence study of Lamotrigine tablets 200 mg of Dr. Reddy's Laboratories Limited, India comparing with that of LAMICTAL® tablets 200 mg of GlaxoSmithKline Inc, in healthy, adult, human subjects under fed condition. 20 subjects (14 male and 6 womens) are enrolled and completed the study. The washout period is 14 days between the two periods of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine Tablets 200 mg | Experimental | Drug: Lamotrigine, Drug: Lamictal®Lamotrigine Tablets 200 mg of Dr. Reddy's Laboratories Limited |
| Lamictal® 200 mg Tablets | Active comparator | Drug: Lamotrigine, Drug: Lamictal®Lamictal® 200 mg Tablets of GlaxoSmithKline Inc |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females at least 18 years of age inclusive
- Informed of the nature of the study and given written informed consent
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.
Key exclusion criteria (8 listed)
- Hypersensitivity to Lamotrigine (Lamictal®) or similar compounds or any history of seizures or clinically significant neurological conditions.
- Any history of a clinical condition which might affect drug absorption, metabolism or excretion
- Recent history of mental illness, drug addition,drug abuse or alcoholism
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing of difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
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 |
|---|---|---|
| LamotrigineAlso: Lamictal® 200 mgLamotrigine Tablets 200 mg | Drug | Lamictal® 200 mg Tablets, Lamotrigine Tablets 200 mg |
| Lamictal®Lamictal® 200 mg Tablets | Drug | Lamictal® 200 mg Tablets, Lamotrigine Tablets 200 mg |
Primary outcome
Area under curve (AUC)
Time frame: Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 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 20 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.
Dr. Ralph Scallion, MD principal investigator
AAI Clinic
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 Lamotrigine and Lamictal® in people with Healthy, run by Dr. Reddy's Laboratories Limited 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 3 inclusion and 8 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 20 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 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?
Area under curve (AUC) (time frame: Pre-dose 0.25, 0.5,1,1.5,2,2.5,3,3.5,4,5,6,8,12,24,36,48,72,96,120 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 20 Jan 2012.