None listed
Conditions
Interventions
Intervention1: Dexlansoprazole 60mg: single tablet along with the 200ml Water
Subject will be observed for 24 hours post dosing
Control Intervention1: Pantoprazole 40mg: single tablet along with the 200ml Water. Subject will be observed for 24 hours post dosing
Control Interven
Sponsors
Dr Vatsal Mehta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged between 20-35 years (both inclusive) 2. Subjects’ weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases. 3. Ability to communicate effectively with study personnel. 4. Normal health as determined by personal medical history, and clinical examination during screening 5. Willingness to adhere to the protocol requirements. 6. Be able to give consent for participation in the trial
Exclusion criteria
Exclusion criteria: 1. History of anaphylaxis or hypersensitivity reaction to benzimidazoles, dexlansoprazole. Pantoprazole, esomeprazole, rabeprazole or any other PPI 2. Subjects who have used any medication / vaccine / medical intervention in last 2 weeks prior to screening 3. Subjects with history of gastritis, acidity, gastric ulcer. 4. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement 5. History or presence of significant alcoholism or drug abuse within the past one-year. 6. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco product. Subjects who cannot abstain from smoking / chewing tobacco for at least 36 hours during dosing period 7. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg. 8. Pulse less than 60/minute or more than 110/minute. 9. Febrile. 10. Any ECG abnormalities 11. Major illness during 3 months before the screening period 12. Subjects who have participated in drug research studies within past 3 months. 13. Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 14. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total duration (in minutes) for which pH remains 4 or morethan thatTimepoint: Total duration (in minutes) for which pH remains 4 or morethan that | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported in the studyTimepoint: During the study;Serious Adverse event reported in the studyTimepoint: During the study;Total duration (in minutes) for which pH remains = 4Timepoint: For First 12 hours and Last 12 Hours | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed