None listed
Conditions
Interventions
Intervention1: NAL1282 Lidocaine 5% Patch: In each period after an overnight fasting of at least 10.00 hours in the morning a NAL1282 Lidocaine 5% Patch 3 patches will be applied to the same anatomica
Sponsors
NAL Pharmaceutical Group Limited
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
Inclusion criteria: Normal healthy adult human subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 30.00 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 consume non vegetarian diet Willing to comply to all requirements of this study protocol as well as instructed by the study personnel Non smokers Generally healthy as documented by gynaecological examination and breast examination for female subjects period I only Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period If subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subject s last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy or is of childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide intrauterine device IUD with a low failure rate of less than 1 percentage per year or is of childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active
Exclusion criteria
Exclusion criteria: Evidence of allergy or known hypersensitivity to Lidocaine or its inactive ingredients Positive results for Allergic test prior to check in of study period Subjects with allergic to two or more substances dust pollen food medicine etc skin products soap lotion skin cream ointment cream cosmetics adhesives or latex adhesive dressing or other skin patches and or ingredients contained in the patch lidocaine tetracaine amide or ester anesthetics Subjects with any disease that increases the risk of bleeding such as acute gastritis or active ulcer with bleeding clinically significant thrombocytopenia or anaemia active pathological bleeding and or a history of intracranial haemorrhage Skin of the application site on the back was oily just shaved or damaged inflamed red or rash with skin diseases untreated or Medical history of significant dermatologic diseases or conditions, such as atopy psoriasis vitiligo or conditions known to alter skin appearance or physiologic response eg diabetes or porphyria Medical history of a condition that would significantly influence the immune response eg primary or acquired immuno deficiencies such as HIV or AIDS allergic diseases such as anaphylaxis asthma or generalized drug reaction neoplasms such as lymphoma or leukaemia rheumatoid arthritis or systemic lupus erythematosus Within 3 weeks of the start of study treatment use of medications or treatments that would either 1 significantly influence or exaggerate responses to the T or R product or 2 alter the inflammatory or immune response to the T or R product eg cyclosporine tacrolimus systemic or topical corticosteroids cytotoxic drugs immune globulin Bacillus Calmette Guerin monoclonal antibodies or radiation therapy History of skin cancer such as melanoma and squamous cell carcinoma, except for superficial basal cell carcinoma that does not involve the drug site and or the situation might affect drug absorption such as excessive hair scars tattoos abnormal skin color 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 on-going chronic medical illness Renal or liver impairment Any disease or condition which might compromise the haemopoeitic gastrointestinal renal cardiovascular Musculoskeletal respiratory central nervous system Or any other body system presence of Diabetes Mellitus and Psychosis Medical history of hepatic disease History of alcohol addiction or abuse Consumption of caffeine and or Xanthine containing products ie coffee tea chocolate and caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 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 A list of the prescription and over-the-counter drug products procedures and activities that are prohibited during the study should be included in the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the relative bioequivalence of NAL1282 Lidocaine 5% Patch Manufactured by Teh Seng Pharmaceutical Mfg Co Ltd compared to the LIDODERM Lidocaine Patch 5% Manufactured by Teikoku Pharma USA Inc in healthy adult human subjectsTimepoint: 17 Time points 00.00 hrs 02.00 hrs 04.00 hrs 06.00 hrs 08.00 hrs 09.00 hrs 10.00 hrs 11.00 hrs 12.00 hrs 13.00 hrs 14.00 hrs 15.00 hrs 16.00 hrs 20.00 hrs 24.00 hrs 30.00 hrs 36.00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety tolerability adhesion and skin irritation and sensitization of Test and Reference product applied in healthy adult human subjectTimepoint: 17 Time points 00.00 hrs 02.00 hrs 04.00 hrs 06.00 hrs 08.00 hrs 09.00 hrs 10.00 hrs 11.00 hrs 12.00 hrs 13.00 hrs 14.00 hrs 15.00 hrs 16.00 hrs 20.00 hrs 24.00 hrs 30.00 hrs 36.00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Life science and research private limited
Outcome results
None listed