A Randomized, Open-label, Balanced, Two-period, Two-treatment, Two way Cross-over Study For Studying the Absorption of Test Product: D-LIGHTâ?¢ (Vitamin D3 Oral Spray) in comparison with Reference Product: Uprise-D3 (Vitamin D3 Capsule 1000 IU) In Healthy and Unhealthy Subjects Under Fed Conditions After One Month Dose Administrations.

Pharma Base SA0 个研究点目标入组 209 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Written informed consent for participation in the study by the subject.
•2.Subjects of either sex, between 18 and 65 years of age (both inclusive).
•3.Having a Body Mass Index (BMI) between 18.0 and 30.0 (kg/m2).
•4.Able to comply with study procedures in the opinion of the investigator.
•5.For healthy subjects:
•5.1Not having any significant diseases or clinically significant abnormal findings during medical history, physical examination, laboratory evaluations etc.
•5.2Subject having no any history of significant smoking habit (more than 10 cigarettes or beedi (Indian cigarette)â??s/day).
•6.For unhealthy subjects:
•6.1Subjects with confirmed diagnosis of any one of the following Malabsorption disease condition:
•Ulcerative Colitis
•Steatorrhoea

•1.Subjects who are already taking a vitamin D supplement regularly (once per week or more), or travelling to sunny areas or using a tanning bed during the previous 3 months.
•2.Subjects with history of uncontrolled hypertension.
•3.Seated blood pressure less than 110/70 mmHg or pulse rate less than 60 or more than 100 beats per minute at screening.
•4.Subjects with history of hypercalcemia, hyperparathyroidism or osteomalacia.
•5.History or presence of cancer.
•6.Difficulty in swallowing solids like tablets or capsules.
•7.Subjects with history of peptic ulcer disease, frequent dyspepsia or bleeding.
•8.Subjects with moderate or severe cognitive impairment.
•9.No history of any medical condition or addictive disorder or laboratory abnormality that may increase the risks associated with disease condition in unhealthy subjects.
•10.Positive screening test for any one or more: HIV I & II and Hepatitis B.
•11.Any food allergy, intolerance, restriction or special diet that, in the opinion of the investigator could contraindicate the subjectâ??s participation in this study.
•12.Subjects with any condition which in the opinion of the investigator makes the subject unsuitable for inclusion.
•13.Female subject who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.

发起方

Pharma Base SA