| Eligibility |
Inclusion Criteria:
1. Healthy, non-smoking (for at least 6 months prior to first drug administration), male
volunteers 18 to 65 years of age inclusive.
2. BMI that was within 18.5-30.0 kg/m², inclusive.
3. Healthy, according to the medical history, ECG, vital signs, laboratory results and
physical examination as determined by the PI/Sub-Investigator.
4. QTcB interval < 440 milliseconds for males, unless deemed otherwise by the PI/Sub-
Investigator.
5. 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.
6. 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".
7. 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.
8. Ability to fast for at least 14 hours and consume standard meals.
9. Availability to volunteer for the entire study duration and was willing to adhere to
all protocol requirements.
10. Agreed not to have a tattoo or body piercing until the end of the study.
11. 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.
12. 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.
13. Agreed not to drive or operate heavy machinery if feeling dizzy or drowsy following
study drug administration until full mental alertness was regained.
14. 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.
Medically acceptable methods of contraception included using a condom with a female partner
of child-bearing potential who was using oral contraceptives, hormonal patch, implant or
injection, intrauterine device, or diaphragm with spermicide. Abstinence as a method of
contraception was acceptable if it was in line with the preferred and usual lifestyle of
the study participant. If a subject's partner became pregnant during his participation in
the study and for 30 days after he had completed his last study drug administration, he
must have informed BPSI staff immediately.
Exclusion Criteria:
1. 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.
2. 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.
3. Presence of any clinically significant illness within 30 days prior to first dosing,
as determined by the PI/Sub-Investigator.
4. Presence of any significant physical or organ abnormality as determined by the
PI/Sub-Investigator.
5. 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.
6. 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".
- Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
7. Intolerance to and/or difficulty with blood sampling through venipuncture.
8. Abnormal diet patterns (for any reason) during the four weeks preceding the study,
including fasting, high protein diets etc.
9. Individuals who had donated, in the days prior to first study drug administration:
- 50-499 mL of blood in the previous 30 days;
- 500 mL or more in the previous 56 days.
10. Donated plasma by plasmapheresis within 7 days prior to first study drug
administration.
11. Individuals who had participated in another clinical trial or who received an
investigational drug within 30 days prior to first study drug administration.
12. Use of any enzyme-modifying drugs and/or other products, including strong inhibitors
of cytochrome P450 (CYP) enzymes (e.g., cimetidine, fluoxetine, quinidine,
erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals)
and strong inducers of CYP enzymes (e.g., barbiturates, carbamazepine,
glucocorticoids, phenytoin, St. John´s Wort, and rifampicin) in the previous 30 days
before first study drug administration.
13. Used any prescription medication within 14 days prior to first study drug
administration (except for spermicidal/barrier contraceptive products).
14. Used of any over-the-counter medications (including oral multivitamins, herbal and/or
dietary supplements) within 14 days prior to first study drug administration (except
for spermicidal/barrier contraceptive products).
15. Used Acetaminophen (Paracetamol) during the study.
16. Consumed food or beverages containing grapefruit and/or pomelo within 10 days prior to
first study drug administration.
17. Consumed food or beverages containing caffeine/methylxanthines, poppy seeds and/or
alcohol within 48 hours before dosing in each study period.
18. Individuals who had undergone any major surgery within 6 months prior to the start of
the study, unless deemed otherwise by PI/Sub-Investigator.
19. Difficulty with swallowing whole tablet.
20. Unable or unwilling to provide informed consent.
21. Had a tattoo or body piercing within 30 days prior to first study drug administration.
22. Recent history (within 8 weeks prior to screening) of travel to or emigration from any
country with high incidence for tuberculosis.
23. History or presence of tuberculosis or a positive QUANTIFERON blood test/Tuberculin
Skin Test result.
24. A subject who, in the opinion of the investigator or designee, is considered
unsuitable or unlikely to comply with the study protocol for any reason.
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