HealthyPhase 1NCT02821338
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
A Phase 1 study testing Lamotrigine Extended Release in people with Healthy, run by Food and Drug Administration (FDA) at 1 site in United States.
Trial summary
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lamotrigine Extended Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Apr 2017
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects ≥18 to ≤50 years of age
- Subject is willing and able to provide informed consent
- Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2 at screening
- Body weight greater than or equal to 50 kg at screening
- Subject is a non-smoker and has not used any nicotine containing products within 6 months prior to screening
- Subjects who are considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results and screening ECG in the opinion of the Investigator
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- Subjects who are willing and able to comply with the visit schedule, laboratory tests, pharmacokinetic sampling schedule and other study procedures
- Subjects who are willing and able to maintain their eligibility throughout the study.
- A female study subject must meet one of the following criteria:
- If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
- Progestogen-containing hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- Intrauterine device (without hormones)
- Condom with spermicide
- If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (post menopausal must be confirmed by the subject having a serum follicle stimulating hormone greater than 40mIU/ml at screening). Females of non-childbearing potential must present a proof of partial or total hysterectomy; if such proof is not available, the female will be considered to be of childbearing potential.
- A male study subject must agree to use one of the accepted contraceptive regimens during the study and for at least 90 days after the last dose of the study medication;
- Abstinence from heterosexual intercourse
- Female partner with hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
- Female partner with intrauterine device (with or without hormones)
- Female partner with condom with spermicide used by male study subject
- Female partner of non-childbearing potential
- Male sterilization with absence of sperm in the post vasectomy ejaculate
- A male study subject must agree not to donate sperm during the study and for at least 90 days after the last dose of the study medication
Who cannot join
- Females who are pregnant or are breastfeeding
- Females who are using any estrogen-containing hormonal contraceptives
- History of known clinically significant drug allergies or reactions to lamotrigine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs in the opinion of the Investigator
- Clinically significant history or evidence of gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the Investigator would jeopardize the safety of the subject or impact validity of study results
- Presence of observed abnormality (evidenced from physical examination, ECG, vital signs, or laboratory evaluation) that would be clinically significant in the opinion of the Investigator
- History of regular alcohol consumption exceeding 7 drinks per week for females and 14 drinks per week for males within 6 months of screening
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- Has current or recent history (within the past year) of alcohol or drug abuse or dependence
- Any clinically significant illness in the previous 30 days prior to screening
- Use of any enzyme-modifying drugs, including strong inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and strong inducers of CYP enzymes (such as barbiturates, carbamazepine, glucocorticoids, phenytoin, rifampin, St John's Wort) in the previous 30 days prior to screening
- Known presence of rare hereditary problems of galactose and /or lactose intolerance or glucose-galactose malabsorption
- Unusual dietary habits (e.g., vegan, Atkins), dietary restrictions, and/or food allergies.
- Any planned surgery from the screening visit until the end of the study
- Positive urine screen for alcohol, cotinine and/or drugs of abuse at screening and at each admission of each treatment period
- Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg) or Hepatitis C Antibody (HCVAb)
- Albumin values less than 4 g/dL at screening
- Triglyceride values greater than 200 mg/dL at screening
- Treatment with any investigational drug 30 days prior to screening
- Participation in other clinical studies within 30 days prior to screening
- Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
- Subject is unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research, Inc
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, 2-Sequence, 2-Treatment, 4-Period, Open-Label, Single Dose, Fully Replicated Comparative Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects Under Fed Conditions
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.
Read the detailed description
This is a single center, randomized, open-label, single dose, two treatment, four-period, two-sequence, fully replicated crossover design in the fed state.
The study will include two treatments:
- Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.
- Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.
A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will complete the 4-period replicate design. For each treatment period, subjects will be confined from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to the clinical site for the remaining blood samples. There will be a minimum 14-day washout between doses.
Subject participation from the Screening Visit to the Follow-Up Visit will be approximately 71 days.
- Conditions
- Healthy
- Being tested
- Lamotrigine Extended Release
- Keywords
- Bioequivalence, Lamotrigine Extended Release, Generic, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine Extended ReleaseDrug
Also called Lamictal XR
Lamotrigine Extended Release (generic) and Lamictal XR (brand).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Active comparator | The treatments will be administered according to a randomly assigned pre-generated sequence involving the randomized, four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). Receives: Drug: Lamotrigine Extended Release |
| Sequence 2 | Active comparator | The treatments will be administered according to a randomly assigned pre-generated sequence involving the four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). Receives: Drug: Lamotrigine Extended Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Lamotrigine Concentration vs. Time Curve From Sample Time Point 0 Hour to Sample Time Point 144 Hour.
Pre-dose, and post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours
Lamotrigine and Lamictal have the same active ingredient "Lamotrigine."
Measured: 144 hours
AUC 0-Inf
Area Under the Lamotrigine Concentrations vs. time curve from sample time point 0 hour to sample time point 144hours plus extrapolation to infinity of the terminal concentration slope. This describes the total exposure to Lamotrigine. Sampling times include: Pre-dose, and post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours.
Lamotrigine and Lamictal have the same active ingredient.
Measured: 144 hours
Cmax
The maximum concentration of the Lamotrigine achieved in specified time frame for each treatment. Sampling times include: post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours.
Lamotrigine and Lamictal have the same active ingredient.
Measured: 2 to 144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionApr 2017
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- Vince & Associates Clinical Research, Inc., Algorithme Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Bradley Vince, D.O., Principal investigator, Vince and Associates Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821338
- Sponsor's protocol ID
- 15-099D
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2016
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 2-Sequence, 2-Treatment, 4-Period, Open-Label, Single Dose, Fully Replicated Comparative Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT02821338
- Acronym / sponsor ID
- 15-099D
- Conditions
- Healthy
- Keywords
- Bioequivalence, Lamotrigine Extended Release, Generic, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- Vince & Associates Clinical Research, Inc., Algorithme Pharma Inc
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.
Detailed description
This is a single center, randomized, open-label, single dose, two treatment, four-period, two-sequence, fully replicated crossover design in the fed state.
The study will include two treatments:
- Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.
- Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.
A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will complete the 4-period replicate design. For each treatment period, subjects will be confined from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to the clinical site for the remaining blood samples. There will be a minimum 14-day washout between doses.
Subject participation from the Screening Visit to the Follow-Up Visit will be approximately 71 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Active comparator | Drug: Lamotrigine Extended ReleaseThe treatments will be administered according to a randomly assigned pre-generated sequence involving the randomized, four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). |
| Sequence 2 | Active comparator | Drug: Lamotrigine Extended ReleaseThe treatments will be administered according to a randomly assigned pre-generated sequence involving the four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Healthy male or female subjects ≥18 to ≤50 years of age
- Subject is willing and able to provide informed consent
- Body mass index (BMI) greater than or equal to 18.00 kg/m2 and below 30.00 kg/m2 at screening
- Body weight greater than or equal to 50 kg at screening
- Subject is a non-smoker and has not used any nicotine containing products within 6 months prior to screening
Key exclusion criteria (20 listed)
- Females who are pregnant or are breastfeeding
- Females who are using any estrogen-containing hormonal contraceptives
- History of known clinically significant drug allergies or reactions to lamotrigine, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs in the opinion of the Investigator
- Clinically significant history or evidence of gastrointestinal, hepatic, renal, endocrine, pulmonary, neurological, psychiatric, cardiovascular, hematologic, dermatologic, immunologic disease or any other condition known to interfere with the absorption, distribution, metabolism or distribution of drugs that in the opinion of the Investigator would jeopardize the safety of the subject or impact validity of study results
- Presence of observed abnormality (evidenced from physical examination, ECG, vital signs, or laboratory evaluation) that would be clinically significant in the opinion of the Investigator
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 Extended ReleaseAlso: Lamictal XRLamotrigine Extended Release (generic) and Lamictal XR (brand). | Drug | Sequence 1, Sequence 2 |
Primary outcome
Area Under the Lamotrigine Concentration vs. Time Curve From Sample Time Point 0 Hour to Sample Time Point 144 Hour.
Time frame: 144 hours
Pre-dose, and post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours Lamotrigine and Lamictal have the same active ingredient "Lamotrigine."
AUC 0-Inf
Time frame: 144 hours
Area Under the Lamotrigine Concentrations vs. time curve from sample time point 0 hour to sample time point 144hours plus extrapolation to infinity of the terminal concentration slope. This describes the total exposure to Lamotrigine. Sampling times include: Pre-dose, and post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours. Lamotrigine and Lamictal have the same active ingredient.
Cmax
Time frame: 2 to 144 hours
The maximum concentration of the Lamotrigine achieved in specified time frame for each treatment. Sampling times include: post-dose 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 27, 30, 33, 36, 48, 72, 96, 120, 144 hours. Lamotrigine and Lamictal have the same active ingredient.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Bradley Vince, D.O. principal investigator
Vince and Associates Clinical Research
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 Extended Release in people with Healthy, run by Food and Drug Administration (FDA) 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 23 inclusion and 20 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 1 May 2020. 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 1 May 2020). 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?
Area Under the Lamotrigine Concentration vs. Time Curve From Sample Time Point 0 Hour to Sample Time Point 144 Hour. (time frame: 144 hours). 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 1 May 2020.