A prospective, open label, single centre, single arm, clinical endpoint study to evaluate the effect of strontium chloride 10% w/w medicated dental cream on blood glucose levels in healthy adult human male subjects under fasting conditions.

Indoco Remedies Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•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

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