Scintigraphic Study of Rapid-release Formulation of Paracetamol

A Single Centre, Three Treatment, Three Way, Single Oral Dose, Crossover Scintigraphic Study To Investigate The Three Rapid Release Solid Dosage Forms Of Paracetamol Either Tablets Or Granules In Eight Healthy Human (Male And Female) Subjects Under Fasting Condition.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000419

Enrollment

Registered

2010-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Human subjects aged between 18 and 55 years (including both) 2. Subjects weight within Â± 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: Pre-dose 15 min. 30 min. 30-90 min. (every 20 min) 90 min-6 hrs (Every 40-60 min)	—

Secondary

Measure	Time frame
safety of the subjectsTimepoint: Subjects will be monitored throughout the study period for adverse events	—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

vijayajaiswal@troikaapharma.com079-26856242

Outcome results