None listed
Conditions
Interventions
Intervention1: Paracetamol 500 Mg - Manufactured by Troikaa Pharmaceuticals: One Tablet On The Day of Dosing
Control Intervention1: Paracetamol 500 Mg Reference Formulation: One Tablet On The Day Of D
Sponsors
Troikaa Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Human subjects aged between 18 and 55 years (including both). 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. Willingness to adhere to protocol requirement. 5.Be able to give consent for participation in the trial. 6. Normal healthy as determined by person medical history, clinical examination and laboratory examinations data during screening (within clinically acceptable range).
Exclusion criteria
Exclusion criteria: 1.History of hypersensitivity to any allergens known to them. 2.History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric or any other body system involvement. 3.History of significant symptoms of cardiac dysfunction within one year. 4.Any history or presence of significant alcoholism or drug abuse within past one year. 5.History or presence of significant smoking (10 or more cigarettes per day) or consumption of tobacco product. 6.History or presence of significant asthma, urticaria or other allergic reactions following aspirin. 7.History or presence of significant gastric and/or duodenal ulceration. 8.History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor. 9.History or presence of cancer. 10.Blood pressure less than 90/60 (Systolic/ diastolic) mm Hg or more than 140/95 mm Hg. 11.Pulse less than 45/minute or more than 110/minute. 12.Febrile. 13.Use of any prescribed medication during last two weeks or OTC medicinal products during the last one-week preceding the study. 14.Major illness during 3 months before the screening period. 15.Subjects who have been on abnormal diet for whatever reason during 4 weeks preceding the study. 16.Subjects who have participated in drug research study within past three months. 17.A positive pregnancy test in case of female volunteer of child bearing age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric Disintegration Pattern of a Rapid Release Formulation of ParacetamolTimepoint: Dynamic images will be carried out in first 15-30 minutes. Static images shall be taken initially at 20 minutes interval till 90 minutes and later at 40-60 minutes interval till 6hrs. For Blood sample collection: The blood samples will be withdrawn at pre-dose, 15Min. 30Min. 45Min following drug administration in each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Of The SubjectTimepoint: Subjects Will Be Monitored Throughout The Study Period For Adverse Events. | — |
Countries
India
Contacts
Public ContactDr Vijaya Jaiswal
Troikaa Pharmaceuticals Limited
Outcome results
None listed