None listed
Conditions
Interventions
Intervention1: Apixaban 5 mg Oral Solution (1mg/ml) Manufactured by XL Laboratories Pvt Ltd, 430 DLF Towers, Shivaji Marg, New Delhi, 110015, India: A Single oral dose Apixaban 5 mg Oral Solution (1mg
Sponsors
Mahashiv 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 according to the formula BMI weight (kg) height (m)2 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 are 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 not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from 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 the initiation of the study and a negative urine pregnancy test prior to check-in for each period If the 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 subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of non childbearing potential defined as less than 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% 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 Apixaban 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 Active bleeding or high risk for bleeding Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing products i.e coffee tea chocolate 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 any 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 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 the start of the 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 are likely to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioavailability of Apixaban 5 mg Oral Solution 1mg/ml Manufactured by XL Laboratories Pvt Ltd 430 DLF Towers Shivaji Marg New Delhi 110015 India with Eliquis (Apixaban 5 mg Film Coated Tablets) Marketing Authorisation Holder Bristol Myers Squibb Pfizer Eeig Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting ConditionsTimepoint: 28 Time Points 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 42 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fasting conditionsTimepoint: 28 Time Points 00 00 hrs 00 08 hrs 00 16 hrs 00 25 hrs 00 33 hrs 00 42 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 33 hrs 01 67 hrs 02 00 hrs 02 33 hrs 02 67 hrs 03 00 hrs 03 33 hrs 03 67 hrs 04 00 hrs 04 33 hrs 04 67 hrs 05 00 hrs 05 50 hrs 06 00 hrs 08 00 hrs 10 00 hrs 24 00 hrs 48 00 hrs and 72 00 hrs | — |
Countries
India
Contacts
Public ContactDr Pradeep T
Spinos Lifescience and research private limited
Outcome results
None listed