Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

NCT05145608 | Completed Phase 1 FDA Drug

• 1 other identifier: AMC-P0-215
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• Cmax

  Peak Plasma Concentration (Cmax)

  Up to 192 hours

• AUC0-T

  Area under the plasma concentration versus time curve (AUC)

  Up to 192 hours

• AUC0-∞

  Area under the plasma concentration versus time curve (AUC)

  Up to 192 hours

Study Arms (2)

Test- Lamotrigine ER Tablets USP 50mg

ACTIVE COMPARATOR

Single dose of Test- Lamotrigine ER Tablets USP 50mg will be administered

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

Drug: Lamotrigine ER tablet 50mg

Interventions

Lamotrigine ER tablet 50mg DRUG

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.

Also known as: Reference- Lamictal® XRTM (Lamotrigine) ER tablet 50mg

Reference- Lamictal® XRTM ER tablet 50mg; Test- Lamotrigine ER Tablets USP 50mg

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alembic Pharmaceuticals Ltd.: lead

Study Sites (1)

Algorithme Pharma

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Interventions

Lamotrigine

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eric Sicard, MD

  Algorithme Pharma Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: December 6, 2021
• Study Start: January 10, 2018
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: December 7, 2021

Record last verified: 2021-12

Locations

CA (1)