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Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions (BE)

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ClinicalTrials.gov Identifier: NCT04938856
Recruitment Status : Completed
First Posted : June 24, 2021
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
The Searle Company LTD., Pakistan.
Information provided by (Responsible Party):
Dr. Muhammad Raza Shah, University of Karachi

Tracking Information
First Submitted Date  ICMJE June 12, 2021
First Posted Date  ICMJE June 24, 2021
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE September 4, 2020
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2021)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2021)
  • Blood Pressure monitoring [ Time Frame: 0-120 hours post dose ]
    monitoring if blood pressure after dose administration
  • Body temperature measurement [ Time Frame: 0-120 hours post dose ]
    Measurement of body temprature after dose administration
  • Heart rate measurement [ Time Frame: 0-120 hours post dose ]
    Measurement of heart rate after dose administration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioequivalence of Lamnet (Lamotrigine)100mg Tablet With the Reference Product Lamictal 100mg (Lamotrigine) Tablet Under Fasting Conditions
Official Title  ICMJE 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
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
open label, randomized, single-dose, 2 way cross-over study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Bioequivalence
Intervention  ICMJE Drug: Lamotrigine tablet
Lamotrigine 100 mg immediate release Tablet
Other Name: Test Group (Lamnet 100 mg), Reference Group (Lamictal 100 mg)
Study Arms  ICMJE
  • Experimental: Test Group
    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.
    Intervention: Drug: Lamotrigine tablet
  • Active Comparator: Reference Group
    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.
    Intervention: Drug: Lamotrigine tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2021)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 25, 2020
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Pakistani Population
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04938856
Other Study ID Numbers  ICMJE CB-026-LAM-2018/Protocol/2.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The study related information can be obtained via proper request to the PI unless the confidentiality of the participants are not compromised.
Responsible Party Dr. Muhammad Raza Shah, University of Karachi
Study Sponsor  ICMJE University of Karachi
Collaborators  ICMJE The Searle Company LTD., Pakistan.
Investigators  ICMJE
Principal Investigator: Muhammad R Shah, PhD Center for bio-equivalence studies and clinical research, ICCBS, University of Karachi
PRS Account University of Karachi
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP