None listed
Conditions
Interventions
Intervention1: Mexiletine Hydrochloride Capsule: 200 Mg
Oral Dose
2 Times (each period 1 time)
Control Intervention1: Mexiletine Hydrochloride Capsule: 200 Mg
Oral Dose
2 Times (each period 1 time)
Sponsors
DAWA Limited
Eligibility
Inclusion criteria
Inclusion criteria: Extensive metabolisers as proven by testing cytochrome P450-2D6 will be included Normal healthy adult human male subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination (including but may not be limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system) and vital sign assessments Generally healthy as documented by 12 lead electrocardiogram (ECG) Chest X-Ray and clinical laboratory assessments Willing to ovo lacto vegetarian diet and non vegetarian diet Non smokers or ex smokers Ex smokers are defined as someone who has completely stopped smoking for at least the past 03 months Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
Exclusion criteria
Exclusion criteria: Poor Metabolisers of CYP 2D6 (Which is confirmed by carrying out the cytochrome P450-2D6 test) Evidence of allergy or known hypersensitivity to Mexiletine Hydrochloride or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant ongoing chronic medical illness Renal or liver impairment Any disease or condition which might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or Xanthine containing products containing sodas colas etc cigarettes and tobacco containing products for at least 24.00 hours prior to check in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check in and throughout the study Subjects who have taken an unusual diet for whatever reason (e.g. low salt) for 48.00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Pharmacokinetic parameters of Mexiletine Hydrochloride Capsule 200 mg under fasting and fed conditionTimepoint: 17 Blood Samples 00.00 hour 00.50 hours 01.00 hours 01.50 hours 02.00 hours 02.50 hours 03.00 hours 03.50 hours 04.00 hours 06.00 hours 08.00 hours 16.00 hours 24.00 hours 36.00 hours 48.00 hours 72.00 hours and 84.00 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose administered in healthy human adult male subjects under fasting and fed conditionsTimepoint: 17 Blood Samples 00.00 hour 00.50 hours 01.00 hours 01.50 hours 02.00 hours 02.50 hours 03.00 hours 03.50 hours 04.00 hours 06.00 hours 08.00 hours 16.00 hours 24.00 hours 36.00 hours 48.00 hours 72.00 hours and 84.00 hours | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed