A single center study to characterise in-vivo slow release of DTPA tablet in humans
- Registration Number
- CTRI/2010/091/001359
- Lead Sponsor
- Defence R&D Organisation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 8
1. Adults (18-70 years of age)
2. On no medication
3. Normal swallowing reflux
4. Ability to swallow whole tablets
5. Ability to remain empty stomach for at least 8 hours
1. Patients with gastric conditions: medical or surgical
2. Patients with gall bladder disease or surgery
3. Those unable to lie down in stable condition for scintigraphy
4. Pregnant & lactating women or women of child bearing potential not using medically accepted methods of contraception.
5. Patients with clinically significant renal, respiratory, cardiac, gastrointestinal, hepatic, endocrine or hematological disorders.
6. Patients with abnormalities in gastric function or emptying
7. Patients who have any medical condition which in the judgement of the investigator may render them in appropriate for participation in the trial.
8. Patients who have received any other investigational drug for the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm and quantify gastric retention and release pattern of DPTA from the slow-release gastroretentive DTPA oral formulation through pharmacoscintigraphyTimepoint: NI
- Secondary Outcome Measures
Name Time Method To establish safety & patient acceptability of the developed slow-release gastroretentive DTPA formulationTimepoint: NI