BioequivalencePhase 1BENCT04938856
Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
A Phase 1 study testing Lamotrigine tablet in people with Bioequivalence, run by University of Karachi at 1 site in Pakistan.
Trial summary
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Lamotrigine tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Sep 2020to 25 Oct 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate and temperature), ECG monitoring and laboratory analysis (ie, hematology, blood biochemistry, and urinalysis)and viral serology as determined by the investigator.
- Tested negative for COVID-19 (through COVID-19 antibody testing).
- Subjects should have negative urine test for drugs of abuse (morphine, cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
- Subjects will be able to, understand and sign the Informed Consent Form for Medical Screening during their screening visit and Participation Informed Consent Form on study check-In day.
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- Subject agreed not to use special diet including fasting, high protein diet within the next 4 weeks.
- Subject agreed not to consume Alcohol, cigarette, gutka, caffeine or related xanthines containing foods or beverages (e.g. tea, coffee, cola drinks, chocolates, cocoa) etc and poppy seeds (khash khash) within 48 hours prior to drug administration.
- Subject agreed not to intake prescription drugs within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medicine.
- Subject agreed not to intake non-prescription drugs (OTC) within 14 days prior to first dose of study medicine.
- Subject agreed to discontinue vitamins ,dietary and herbal supplements within 14 days prior to the first dose of study medication.
- Subject agreed not to consume grapefruit and/or its products within 14 days prior to the start of study.
Who cannot join
- Inability to take oral medication.
- Tested positive for COVID-19 (through COVID-19 antibody testing).
- History of smoking (≤3cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subject is allergic to Lamotrigine and any of the product of lamotrigine .
- Subject has received any investigational drug within four weeks.
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- Participated in any clinical trials within 30 days.
- Subjects with salt imbalance in the blood (especially low levels of potassium or magnesium in the blood).
- Donation or loss of more than 450 mL of blood within 3 months prior to the screening.
- History of any significant illness in the last four weeks which might confound in the result of the study or post additional risk in administrating lamotrigine to the subject.
- Concomitant treatment with Valproate, Carbamazepine, phenytoin, phenobarbital, primidone,, rifampin, Estrogen-containing oral contraceptives, Protease inhibitors lopinavir/ritonavir and atazanavir/lopinavir.
- Subjects who test positive for syphilis (VDRL) or who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs Ag) or are carriers of antibodies to hepatitis C virus (anti-HCV) or to the human immunodeficiency virus (HIV-1 or HIV-2).
- Individuals having undergone any major surgery within 3 months prior to the start of the study, unless deemed eligible, otherwise by the Principal Investigator or whomever he/she may designate.
- Subjects with any condition, which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or elimination of drugs.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- History of asthma, anaphylaxis or anaphylactic reactions, severe allergic responses.
- Current or past history of nervous-psychiatric disorder, in the opinion of investigator that the subject is at risk of suicide or with history of suicide behavior/attempt.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Center for Bioequivalence Studies and clinical research
Karachi, Sindh, 75270
About this study
Official title: A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.
Read the detailed description
The study drugs will be administered with 240 mL ambient Temperature water after at least 10 hours fasting in each periods.
Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as AUC0-inf) and (AUC0-t)/ (AUC0-inf).
- Conditions
- Bioequivalence
- Being tested
- Lamotrigine tablet
- Keywords
- Bioequivalence Study, Healthy Volunteers, Pakistani Population, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine tabletDrug
Also called Test Group (Lamnet 100 mg), Reference Group (Lamictal 100 mg)
Lamotrigine 100 mg immediate release Tablet
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Oral administration of Lamnet (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Receives: Drug: Lamotrigine tablet |
| Reference Group | Active comparator | Oral administration of Lamictal (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. Receives: Drug: Lamotrigine tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum plasma concentration of Lamotrigine
Measured: 0-120 hours post dose
AUC
Area Under the Plasma Drug Concentration versus Time curve
Measured: 0 to 120 hours post dose
Tmax
Time required for maximum plasma drug concentration
Measured: 0-120 hours post dose
Secondary outcomes (3)
Blood Pressure monitoring
monitoring if blood pressure after dose administration
Measured: 0-120 hours post dose
Body temperature measurement
Measurement of body temprature after dose administration
Measured: 0-120 hours post dose
Heart rate measurement
Measurement of heart rate after dose administration
Measured: 0-120 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start4 Sep 2020
- Primary completion24 Sep 2020
- Study completion25 Oct 2020
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
- open label, randomized, single-dose, 2 way cross-over study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- The Searle Company LTD., Pakistan.
- Responsible party
- Principal investigator, Dr. Muhammad Raza Shah, University of Karachi
- Investigators
- Prof. Dr. Muhammad R Shah, PhD, Principal investigator, Center for bio-equivalence studies and clinical research, ICCBS, University of KarachiDr. Naghma Hashmi (Co-PI), PhD, Principal investigator, Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938856
- Sponsor's protocol ID
- CB-026-LAM-2018/Protocol/2.0
- Acronym
- BE
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study related information can be obtained via proper request to the PI unless the confidentiality of the participants are not compromised.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized, Single-dose, 2 Way Cross-over Study to Explore the Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions in Healthy Male Pakistani Subjects
- ClinicalTrials.gov ID
- NCT04938856
- Acronym / sponsor ID
- BE / CB-026-LAM-2018/Protocol/2.0
- Conditions
- Bioequivalence
- Keywords
- Bioequivalence Study, Healthy Volunteers, Pakistani Population, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- The Searle Company LTD., Pakistan.
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 25 Oct 2020 (actual)
- First posted
- 24 Jun 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.
Single oral administrations of study drug (Lamnet and Lamictal) in two periods separated by a washout period of 14 days. The washout period will be calculated from day of dosing (Day 2) to at least 14 days post dose in each period.
Detailed description
The study drugs will be administered with 240 mL ambient Temperature water after at least 10 hours fasting in each periods.
Pharmacokinetic parameters include Lamotrigine plasma concentrations at the given sampling times. In each period 18 blood samples for plasma Lamotrigine concentrations will be taken on Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 (at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5 ,4, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours post-dose.) The primary parameters to be analyzed are the maximum plasma concentration (Cmax), area under the plasma concentration-time curve from zero to the time of the last measurable time point t (AUClast or also termed as AUC0-t) and area under the plasma concentration-time curve from zero to infinity (AUCtotal or, also termed as AUC0-inf) and (AUC0-t)/ (AUC0-inf).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label, randomized, single-dose, 2 way cross-over study
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Lamotrigine tabletOral administration of Lamnet (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. |
| Reference Group | Active comparator | Drug: Lamotrigine tabletOral administration of Lamictal (100mg) Tablet after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time-point. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male volunteers aged 18 to 55 years inclusive.
- Subjects with a body mass index from 18.5 to 30 kg/m2 (both inclusive).
- Subjects who are healthy as determined by routine physical examination, including vital sign monitoring (i.e., blood pressure, heart rate and temperature), ECG monitoring and laboratory analysis (ie, hematology, blood biochemistry, and urinalysis)and viral serology as determined by the investigator.
- Tested negative for COVID-19 (through COVID-19 antibody testing).
- Subjects should have negative urine test for drugs of abuse (morphine, cannabinoids will be tested) and alcohol breath analysis at screening and prior to each check-in.
Key exclusion criteria (17 listed)
- Inability to take oral medication.
- Tested positive for COVID-19 (through COVID-19 antibody testing).
- History of smoking (≤3cigarette/day), alcoholism, and positive test for drug of abuse, heavy pan or gutka user as judged by teeth / mouth inspection.
- Subjects with clinically relevant evidence of cardiovascular, gastrointestinal/hepatic, renal, psychiatric, respiratory, urogenital, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, drug hypersensitivity, allergy, endocrine, major surgery or other relevant diseases as revealed by medical history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of drugs or constitute a risk factor when taking study medication.
- Subject is allergic to Lamotrigine and any of the product of lamotrigine .
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 tabletAlso: Test Group (Lamnet 100 mg), Reference Group (Lamictal 100 mg)Lamotrigine 100 mg immediate release Tablet | Drug | Reference Group, Test Group |
Primary outcome
Cmax
Time frame: 0-120 hours post dose
maximum plasma concentration of Lamotrigine
AUC
Time frame: 0 to 120 hours post dose
Area Under the Plasma Drug Concentration versus Time curve
Tmax
Time frame: 0-120 hours post dose
Time required for maximum plasma drug concentration
3 secondary outcomes
Blood Pressure monitoring
Time frame: 0-120 hours post dose
Body temperature measurement
Time frame: 0-120 hours post dose
Heart rate measurement
Time frame: 0-120 hours post dose
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 8 Sep 2022.
- Individual participant dataSharing planned: Yes. The study related information can be obtained via proper request to the PI unless the confidentiality of the participants are not compromised.
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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.
Prof. Dr. Muhammad R Shah, PhD principal investigator
Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi
Dr. Naghma Hashmi (Co-PI), PhD principal investigator
Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi
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 tablet in people with Bioequivalence, run by University of Karachi at 1 site in Pakistan.
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 12 inclusion and 17 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 8 Sep 2022. 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 Pakistan. 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: 0-120 hours post dose). 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 8 Sep 2022.