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WithdrawnEarly Phase 1ACTRN12618001177246

Medlab NanoCelle™ D3 hormone blood level absorption study in healthy adult volunteers.

Sponsor

Medlab Clinical Ltd

Enrollment

8 participants

Start Date

Aug 10, 2018

Study Type

Interventional

Conditions

Vitamin D3 deficiency

Summary

The study investigates the absorption characteristics and safety of Medlab’s NanoCelle D3 (Vitamin D3 as cholecalciferol) administered to 8 healthy individuals. The dose to be administered in 10 sprays/5000 I.U./1.5mL. A total of four 10 mL blood samples will be collected from each participant at 0, 60, 180 and 360 minutes. The total study duration per participant is approximately 7.5 hours.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria3

  • Participants greater than or equal to 18 years of age at time of entry on study;
  • No evidence or documented history of a chronic disease;
  • Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;

Exclusion Criteria12

  • Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
  • Previous history of abnormal blood results i.e., FBE, U and E Liver Function Tests and vital signs;
  • Use of vitamin or mineral supplements 1 week before the study and or known adverse side effects to supplements;
  • Use of pharmaceutical drugs (prescribed or over-the-counter);
  • Female participants who are lactating or pregnant or planning to become pregnant;
  • The current use of any nicotine products including:
  • i) nicotine patches / gum;
  • ii) tobacco smoking;
  • History of alcohol or substance abuse including the use of any illicit drugs;
  • Presence of chronic/acute illnesses including hypertension, high cholesterol, diabetes, obesity, irritable bowel syndrome, inflammatory bowel disease, coeliac disease, sarcoidosis, hyperparathyroidism, histoplasmosis.
  • Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant [i.e. suicide thoughts or euthanasia requests]
  • Vegetarianism

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Interventions

1. To evaluate the absorption characteristics and further safety over a 6-hour period of Medlab Clinical’s NanoCelle™ D3 (Vitamin D3 as Cholecalciferol) [5000 I.U. administered as a single administrat

1. To evaluate the absorption characteristics and further safety over a 6-hour period of Medlab Clinical’s NanoCelle™ D3 (Vitamin D3 as Cholecalciferol) [5000 I.U. administered as a single administration oro-buccal spray/10 sprays/1.5 mL] to healthy participants. 2. Blood samples will be collected from participants at 4 time points over a 6 hours period for PK data. Study staff will administered the above dose to study participants between 8 and 9 am on dosing day (Day 1). A baseline blood sample will be collected from participants prior to the administration of the IP and at 60, 180 and 360 minutes. Unused product will be disposed of at site.

Locations(1)

NSW, Australia

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ACTRN12618001177246