An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Vonoprazan Tablets 20 mg of MSN Laboratories Private Limited India With Voquezna Vonoprazan Tablets 20 mg of Phathom Pharmaceuticals Inc Usa In Healthy Adult Human Subjects Under Fasting Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- To assess the Bioequivalence on Vonoprazan Tablets 20 mg of MSN Laboratories Private Limited India with Voquezna Vonoprazan Tablets 20 mg of Phathom
Study Overview
Brief Summary
Enough volunteers shall be recruited in order to evaluate and start the study with at least 32 subjects as this Bioequivalence study of test product with the Reference product will be conducted on Healthy human Subjects Under Fasting Conditions
As per the discretion of the Investigator a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 32 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11 00 hrs pre dose to 48 00 hrs post dose a washout period of at least 05 days will be maintained between each dosing period
After an overnight fasting of at least 10 00 hours in the morning a single oral dose of either the test product T or reference product V R will be administered
Blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded at pre dose 00 00 hrs within 75 minutes of before dosing and at 01 00 hrs 03 00 hrs 06 00 12 00 hrs and 24 00 hrs plus or minus 60
minutes post dose
Physical examination and vitals will be recorded before check in check out 48 00 hrs for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Normal healthy adult human subjects of age between 18 45 years and Body Mass Index BMI ranges between 18.50 kg per m2 to 29.99 kg per m2 Subjects who have no evidence of underlying disease during screenmg and checkin 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 or 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 and to provide written informed consent 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 greater or equal to 01 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 tUD with a low failure rate of lesser than 01 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
- •Evidence of allergy or known hypersensitivity to Vonoprazan or its inactive ingredients Allergic reaction symptoms may include trouble breathing rash itching and swelling of your face lips tongue or throat 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 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 lor xanthine containing products ie 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 vitamins herbal medications within 07 days prior to study check in and throughout the study Subjects who have taken any 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 I excess blood loss within 90 days of checkin Ingestion of any hormonal agent at any time within 14 days prior to the start of the study checkin Use of hormone replacement therapy for a period of 06 months prior to dosing History or contraindicated with rilpivirine containing products History of Presence of Gastric Malignancy Vitamin B 12 Cobalamin Deficiency Fundic Gland Polyps Neuroendocrine Tumors Acute Tubulointerstitial Nephritis Clostridioides difficile and Associated Diarrhea Hypomagnesemia and Mineral Metabolism 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.
Outcomes
Primary Outcomes
To assess the Bioequivalence on Vonoprazan Tablets 20 mg of MSN Laboratories Private Limited India with Voquezna Vonoprazan Tablets 20 mg of Phathom
Time Frame: 24 samples | 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 33 hrs 02 67hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 and 48 00 hrs
Pharmaceuticals Inc Usa In Healthy Adult Human Subjects Under Fasting Conditions
Time Frame: 24 samples | 00 00 hrs 00 25 hrs 00 50 hrs 00 75 hrs 01 00 hrs 01 25 hrs 01 50 hrs 01 75 hrs 02 00 hrs 02 33 hrs 02 67hrs 03 00 hrs 03 50 hrs 04 00 hrs 04 50 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 16 00 hrs 24 00 hrs 36 00 and 48 00 hrs
Secondary Outcomes
- To monitor the safety and tolerability of test product comparing with the reference product in healthy adult human subjects under fasting conditions(24 samples)
Investigators
Dr Pradeep T
Spinos Lifescience and research private limited