HealthyPhase 1NCT00939458
Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions
A Phase 1 study testing Lamotrigine in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in India.
Trial summary
Objective: To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healthy
- What is being tested?
- Lamotrigine
- How many people
- Not given
- Where
- 1 siteIndia
- Study dates
- Start not givento not given
- 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 55 years
- All sexes
- Adult
Who may be able to join
- Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2
- Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 11.3 of the protocol.
- Female Subjects:
- of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- postmenopausal for at least 1 year.
- surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Who cannot join
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year.
- Moderate to heavy smoking (> 10 cigarettes/day) or consumption of tobacco products.
- History of difficulty in swallowing tablet.
- Clinically significant illness within 4 weeks before the start of the study
- Asthma, urticaria or other allergic type reactions after taking any medication.
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- Positive urine drug screening, HIV, Hepatitis B \& C tests.
- Any history of hypersensitivity to Lamotrigine.
- Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
- Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development/impaired cerebral function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects,Under Fed Conditions
- Objective:
- To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions.
- Study Design:
- A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.
- Conditions
- Healthy
- Being tested
- Lamotrigine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939458
- Sponsor's protocol ID
- 1087/06
- Status last verified
- Oct 2017
- First submitted
- 13 Jul 2009
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, Crossover, Bioequivalence Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects,Under Fed Conditions
- ClinicalTrials.gov ID
- NCT00939458
- Acronym / sponsor ID
- 1087/06
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 15 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.
- Objective:
- To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions.
- Study Design:
- A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2
- Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 11.3 of the protocol.
- Female Subjects:
Key exclusion criteria (10 listed)
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year.
- Moderate to heavy smoking (> 10 cigarettes/day) or consumption of tobacco products.
- History of difficulty in swallowing tablet.
- Clinically significant illness within 4 weeks before the start of the study
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 |
|---|---|---|
| Lamotrigine | Drug | – |
Primary outcome
Bioequivalence
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 25 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in India.
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 8 inclusion and 10 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 25 Oct 2017. 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 India. 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. 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 25 Oct 2017.