None listed
Conditions
Interventions
Intervention1: Mesalazine Gastro-Resistant Tablets BP 500 mg: A Single oral dose of Mesalazine Gastro-Resistant Tablets BP 500 mg will be administered in each period Total Duration of the study is 29
Sponsors
Sunglow Lifescience Pvt Ltd
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 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 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 Mesalazine or its inactive ingredients Poor Metabolisers of CYP 2D6 Which is confirmed by carrying out the cytochrome P450 2D6 test 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 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 Subjects who have taken an unusual diet for whatever reason eg 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 History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period Positive results for alcohol test prior to check-in of each period Any blood donation / excess blood loss within 90 days of check-in Ingestion of any hormonal agent at any time within 14 days prior to start of study check-in Use of hormone replacement therapy for a Period of 06 months prior to dosing Female subjects demonstrating a positive pregnancy screen Female subjects who are currently lactating Females likely to become pregnant during conduction of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence on Mesalazine Gastro Resistant Tablets BP 500 mg Manufactured by Sunglow Lifescience Pvt Ltd with Salofalk 500mg Mesalazine Gastro Resistant Tablets Marketing Authorization Holder Dr Falk Pharma GmbH Leinenweberstr 5 79108 Freiburg Germany In Healthy Adult Human Male and Female Subjects Under Fed ConditionsTimepoint: 23 Time points 00.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 09.00 Hrs 10.00 Hrs 10.50 Hrs 11.00 Hrs 11.50 Hrs 12.00 Hrs 12.50 Hrs 13.00 Hrs 13.50 Hrs 14.00 Hrs 15.00 Hrs 16.00 Hrs 18.00 Hrs 20.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human male and female subjects under fed conditionsTimepoint: 23 Time points 00.00 Hrs 04.00 Hrs 05.00 Hrs 06.00 Hrs 07.00 Hrs 08.00 Hrs 09.00 Hrs 10.00 Hrs 10.50 Hrs 11.00 Hrs 11.50 Hrs 12.00 Hrs 12.50 Hrs 13.00 Hrs 13.50 Hrs 14.00 Hrs 15.00 Hrs 16.00 Hrs 18.00 Hrs 20.00 Hrs 24.00 Hrs 36.00 Hrs 48.00 Hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed