Status:
UNKNOWN
A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects
Lead Sponsor:
Innovus Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.
Detailed Description
This study will be an open label, uncontrolled, ascending dose clinical trial to assess the tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult subjects. In add...
Eligibility Criteria
Inclusion
- Healthy volunteer \> 40 years (adult)
- Systolic blood pressure 90-140 mmHg upon screening
- Subject has provided written informed consent
- Subject is willing to undergo the procedures outlined in this study
- Subjects BMI is within 18-28.
- Subjects of childbearing potential must use a hormonal method of birth control, single-barrier method or a double-barrier method of birth control throughout the study or be documented as medically sterile.
Exclusion
- Subject has clinically significant deviation from normal in any organ system.
- Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
- Pregnant, breastfeeding, or planned pregnancy during the study duration.
- Known liver, renal or muscle diseases.
- History of hypertensive or currently taking anti-hypertensive medications.
- Presence or history of specific heart conditions.
- Currently taking anti-thyroid or thyroid replacement medications.
- Currently taking any creatinine kinase lowering drug or supplement.
- Use of investigational drug within the previous 30 days.
- Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
- Known allergies or intolerance to ingredients in Musclin™
- Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.
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Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03767504
Start Date
November 13 2018
End Date
February 28 2019
Last Update
December 6 2018
Active Locations (1)
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1
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409