Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions

NCT06199791 | Completed Phase 1

• 1 other identifier: LTG-008/K
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the bioequivalence of lamotrigine from Lamotrigin Desitin 100 mg tablets and Lamictal 100 mg Tablet.

Conditions

Fasting

Outcome Measures

Primary Outcomes (2)

• Area under the curve (AUC)

  To establish bioequivalence, the calculated 90% CI for the ratio of geometric means for AUC72 and Cmax for lamotrigine should fall within 80.00%-125.00%.

  blood sampling: pre-dose (0) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose

• Maximal plasma concentration (Cmax)

  To establish bioequivalence, the calculated 90% CI for the ratio of geometric means for AUC72 and Cmax for lamotrigine should fall within 80.00%-125.00%.

  blood sampling: pre-dose (0) and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 36, 48 and 72 hours post-dose

Study Arms (2)

Lamotrigine 100 mg oral tablet

EXPERIMENTAL

Test

Drug: Lamotrigine 100 MG

Lamictal 100 mg oral tablet

ACTIVE COMPARATOR

Reference

Drug: Lamotrigine 100 MG

Interventions

Lamotrigine 100 MG DRUG

tablets

Also known as: Lamotrigin Desitin 100 mg

Lamictal 100 mg oral tablet; Lamotrigine 100 mg oral tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-smoking (for at least 6 months prior to first drug administration), male volunteers 18 to 65 years of age inclusive.
• BMI that was within 18.5-30.0 kg/m², inclusive.
• Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the PI/Sub-Investigator.
• QTcB interval \< 440 milliseconds for males, unless deemed otherwise by the PI/Sub- Investigator.
• Systolic blood pressure between 95-140 mmHg, inclusive, and diastolic blood pressure between 55-90 mmHg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the PI/Sub-Investigator.
• Clinical laboratory values within BPSI's most recent acceptable laboratory test range, and/or values were deemed by the PI/Sub-Investigator as "Not Clinically Significant".
• Ability to comprehend and be informed of the nature of the study, as assessed by BPSI staff. Capable of giving written informed consent prior to any study-related procedure.
• Must have been able to communicate effectively with clinic staff.
• Ability to fast for at least 14 hours and consume standard meals.
• Availability to volunteer for the entire study duration and was willing to adhere to all protocol requirements.
• Agreed not to have a tattoo or body piercing until the end of the study.
• Agreed not to receive the COVID-19 vaccination from 7 days prior to the first study drug dose until 7 days after the last study drug administration in the study.
• Agreed to limit exposure to sunlight and UV light by wearing protective clothing and using a sunscreen with a high protection factor during the study.
• Agreed not to drive or operate heavy machinery if feeling dizzy or drowsy following study drug administration until full mental alertness was regained.
• Males who were able to father children agreed to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration.

You may not qualify if:

• Known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the PI/Sub-Investigator.
• Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g., chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug experienced within 7 days prior to first study drug administration, as determined by the PI/Sub-Investigator.
• Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the PI/Sub-Investigator.
• Presence of any significant physical or organ abnormality as determined by the PI/Sub-Investigator.
• A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol breath test and cotinine.
• Known history or presence of:
• Alcohol abuse or dependence within one year prior to first study drug administration.
• Drug abuse or dependence within the last 2 years.
• Prior history or family history of hypersensitivity or idiosyncratic reaction to any drug including but not limited to Lamotrigine, its excipients, and/or related substances;
• Suicidal ideation or suicidal behavior, as assessed by the Columbia Suicide Severity Rating Scale (baseline version) - Appendix B (Refer to Appendix 16.1.1)
• Prior history or family history of allergic drug rash to any drug including but not limited to lamotrigine, its inactive ingredients and/or any other related marketed drugs, including Lamictal XR and Lamictal.
• Prior history or family history of Stevens-Johnson Syndrome (SJS);
• Lactose intolerance;
• Food allergies;
• Presence of any dietary restrictions unless deemed by the PI/Sub-I as "Not Clinically Significant".

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead
• BioPharma Services Inc.: collaborator

Study Sites (1)

Biopharma Services INC

Toronto, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janice Faulknor, MD

  BioPharma Services 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

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 10, 2024
• Study Start: April 3, 2023
• Primary Completion: May 9, 2023
• Study Completion: June 14, 2023
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)