BioequivalencePhase 1NCT05145608
Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg
A Phase 1 study testing Lamotrigine ER tablet 50mg in people with Bioequivalence, run by Alembic Pharmaceuticals Ltd. at 1 site in Canada.
Trial summary
Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions. The secondary objective is to monitor the safety of the subjects. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Lamotrigine ER tablet 50mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2018to 21 Feb 2018
- 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 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Male or female volunteer
- A female volunteer must meet one of the following criteria:
- Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug. An acceptable method of contraception includes one of the following:
- Abstinence from heterosexual intercourse
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- Intrauterine device (without hormones)
- Condom with intra-vaginally applied spermicide or
- Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
- Volunteer aged of at least 18 years to 54 years of age, inclusively
- Volunteer with a BMI within 22.00 to 30.00 kg/m2, inclusively
- Minimum body weight of 60 kg
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 6 months before day 1 of this study
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, must be without any clinical significance
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, general biochemistry, ECG and urinalysis)
- Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer The informed consent form must be signed by all volunteers prior to their participation in the study.
Who cannot join
- Difficulty donating blood
- History of difficulty in swallowing or of any gastrointestinal disease which could affect drug absorption
- Volunteer who is associated to Algorithme Pharma (staff member or immediate family of a staff member)
- Females who are pregnant or are lactating
- History of significant hypersensitivity to lamotrigine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- History of any prior allergic drug rash
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- Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
- History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability
- Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS) administered at screening
- Presence of out-of-range cardiac interval (PR < 110 msec, PR > 220 msec, QRS < 60 msec, QRS >119 msec and QTc > 450 msec for males and > 460 msec for females) on the screening ECG or other clinically significant ECG abnormalities
- Known presence of rare hereditary problems of galactose and /or lactose intolerance, lactase deficiency or glucose-galactose malabsorption
- Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
- Any clinically significant illness in the previous 28 days before day 1 of this study
- Use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (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 and St John's Wort), in the previous 28 days before day 1 of this study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive screening of alcohol and/or drugs of abuse
- Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests
- Females who are pregnant according to a positive serum pregnancy test
- Volunteers who took an Investigational Product (in another clinical trial) in the previous 28 days before day 1 of this study
- Volunteers who took an Investigational Product (in another clinical trial) with a long half-life (≥120 hours) in the previous 3 months before day 1 of this study
- Volunteers who took lamotrigine in the previous 28 days before day 1 of this study
- Females who use the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days before day 1 of this study
- Females who use hormone replacement therapy in the 28 days before day 1 of this study
- Females who use the following systemic contraceptives: injections or implant, or hormone-releasing intrauterine device in the previous 13 weeks before day 1 of this study
- Volunteers who donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Two Way Crossover Comparative Bioavailability Study of Lamotrigine Extended-Release Tablets USP 50 mg in Healthy Male and Female Volunteers Fasting State
Objective:
To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions.
The secondary objective is to monitor the safety of the subjects.
Read the detailed description
Study Design:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
Subjects:
Twenty-two (22) subjects will be included in the study.
Main Inclusion Criteria:
Male and female volunteers, non- or ex-smokers, of at least 18 years of age to 54 years of age, inclusively, with a body mass index (BMI) within 22.00 to 30.00 kg/m2, inclusively, with a minimum body weight of 60 kg, will be selected according to the inclusion and exclusion criteria.
Blood Sampling:
In each study period, 23 blood samples will be collected. The first blood sample will be collected prior to drug administration while the others will be collected up to 192 hours after the drug administration.
Wash-out:
The drug administrations will be separated by at least 28 calendar days.
Tests during study:
An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as prior to discharge for each period of the study.
For female subjects, a serum pregnancy test will be performed before each period of the study.
Vital signs will be measured prior to and approximately 2, 4, 8, 10, 12, 24, 36 and 48 hours following each drug administration.
Neurological function tests will be performed approximately 30 hours after each drug administration.
For safety reasons, hematology tests will be performed before the 2nd period of the study.
Post study Tests:
Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study.
A complete physical examination (including vital signs) will also be performed.
Bioanalysis: Lamotrigine plasma concentrations will be measured by a validated bioanalytical method.
- Conditions
- Bioequivalence
- Being tested
- Lamotrigine ER tablet 50mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine ER tablet 50mgDrug
Also called Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg
In each study period, a single 50 mg dose of lamotrigine will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast.
| Study group | Role | What they receive |
|---|---|---|
| Test- Lamotrigine ER Tablets USP 50mg | Active comparator | Single dose of Test- Lamotrigine ER Tablets USP 50mg will be administered Receives: Drug: Lamotrigine ER tablet 50mg |
| Reference- Lamictal® XRTM ER tablet 50mg | Active comparator | Single dose of Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg will be administered Receives: Drug: Lamotrigine ER tablet 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration (Cmax)
Measured: Up to 192 hours
AUC0-T
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 192 hours
AUC0-∞
Area under the plasma concentration versus time curve (AUC)
Measured: Up to 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start10 Jan 2018
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Model description
- Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alembic Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145608
- Sponsor's protocol ID
- AMC-P0-215
- Status last verified
- Dec 2021
- First submitted
- 9 Jan 2018
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Two Way Crossover Comparative Bioavailability Study of Lamotrigine Extended-Release Tablets USP 50 mg in Healthy Male and Female Volunteers Fasting State
- ClinicalTrials.gov ID
- NCT05145608
- Acronym / sponsor ID
- AMC-P0-215
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alembic Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 6 Dec 2021 (actual)
- 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 evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions.
The secondary objective is to monitor the safety of the subjects.
Detailed description
Study Design:
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
Subjects:
Twenty-two (22) subjects will be included in the study.
Main Inclusion Criteria:
Male and female volunteers, non- or ex-smokers, of at least 18 years of age to 54 years of age, inclusively, with a body mass index (BMI) within 22.00 to 30.00 kg/m2, inclusively, with a minimum body weight of 60 kg, will be selected according to the inclusion and exclusion criteria.
Blood Sampling:
In each study period, 23 blood samples will be collected. The first blood sample will be collected prior to drug administration while the others will be collected up to 192 hours after the drug administration.
Wash-out:
The drug administrations will be separated by at least 28 calendar days.
Tests during study:
An alcohol breath test will be performed before each period of the study. Screening for drugs of abuse will be performed before each period of the study. A C-SSRS questionnaire will be performed prior to each study period, as well as prior to discharge for each period of the study.
For female subjects, a serum pregnancy test will be performed before each period of the study.
Vital signs will be measured prior to and approximately 2, 4, 8, 10, 12, 24, 36 and 48 hours following each drug administration.
Neurological function tests will be performed approximately 30 hours after each drug administration.
For safety reasons, hematology tests will be performed before the 2nd period of the study.
Post study Tests:
Hematology, general biochemistry (including a serum pregnancy test for female subjects), and urinalysis tests will be repeated along with the collection of the last blood sample of the study.
A complete physical examination (including vital signs) will also be performed.
Bioanalysis: Lamotrigine plasma concentrations will be measured by a validated bioanalytical method.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
| Arm | Type | Receives |
|---|---|---|
| Test- Lamotrigine ER Tablets USP 50mg | Active comparator | Drug: Lamotrigine ER tablet 50mgSingle dose of Test- Lamotrigine ER Tablets USP 50mg will be administered |
| Reference- Lamictal® XRTM ER tablet 50mg | Active comparator | Drug: Lamotrigine ER tablet 50mgSingle dose of Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg will be administered |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee
- Male or female volunteer
- A female volunteer must meet one of the following criteria:
- Volunteer aged of at least 18 years to 54 years of age, inclusively
Key exclusion criteria (27 listed)
- Difficulty donating blood
- History of difficulty in swallowing or of any gastrointestinal disease which could affect drug absorption
- Volunteer who is associated to Algorithme Pharma (staff member or immediate family of a staff member)
- Females who are pregnant or are lactating
- History of significant hypersensitivity to lamotrigine or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
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 ER tablet 50mgAlso: Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mgIn each study period, a single 50 mg dose of lamotrigine will be administered orally with about 240 mL of water at ambient temperature, in the morning, while subjects are seated, following a 10-hour overnight fast. | Drug | Reference- Lamictal® XRTM ER tablet 50mg, Test- Lamotrigine ER Tablets USP 50mg |
Primary outcome
Cmax
Time frame: Up to 192 hours
Peak Plasma Concentration (Cmax)
AUC0-T
Time frame: Up to 192 hours
Area under the plasma concentration versus time curve (AUC)
AUC0-∞
Time frame: Up to 192 hours
Area under the plasma concentration versus time curve (AUC)
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 7 Dec 2021.
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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 Sicard, MD principal investigator
Algorithme Pharma Inc
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 ER tablet 50mg in people with Bioequivalence, run by Alembic Pharmaceuticals Ltd. 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 16 inclusion and 27 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 7 Dec 2021. 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?
Cmax (time frame: Up to 192 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 7 Dec 2021.