A clinical endpoint study to assess the effect of dental cream, strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy male subjects.
- Registration Number
- CTRI/2024/05/068009
- Lead Sponsor
- Indoco Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy human male subjects within the age range of 18 to 55 years (inclusive of both)
2. Body-mass index of more than or equal to 18.5 kg/m2 and less than or equal to 30.0 kg/m2, with body weight not less than 50 kg.
3. Willingness to provide written informed consent to participate in the study.
4. Absence of significant disease, laboratory examinations within acceptable range, medical history and with normal physical examination during the screening.
5. Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
1. Personal / family history or presence of allergy or hypersensitivity to Strontium Chloride or to any of the components of the formulations.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Presence of tooth sensitivity
4. Difficulty in brushing due to tooth decay
5. History of donation of blood (one unit) within 3 months prior to study check-in or difficulty in donating blood.
6. Participation in a drug research study within past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method