Regulatory guidance for recruiting healthy male volunteers in a Lochol safety study

Regulatory Guidance for Subject Recruitment

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ABC Pharmaceuticals Company

Tolerance study of Lochol in healthy male

Volunteers Wanted for a Research Study

The research above will basically be a randomized, double-blind, placebo-controlled, multiple-dose safety and tolerance study of LOCHOL in healthy male volunteers. The ultimate aim or objective of the research will be to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of 250 mg Lochol when administered once daily for 2 weeks. I is for these above mentioned purposes that the ABC Pharmaceuticals Company is seeking volunteers who will be able to fully participate in the research for the 2 weeks period.

In order to participate in the research, the volunteer will have to be available for reach by the researcher 6 weeks before the administering of the test, a period that will allow the researcher to carry out thorough screening on the volunteer. The individual will also have to be a male who is healthy and not less than 18 years old and no more than 65 years old. The volunteer must also have LDL values which is more than 100 mg/dL. The volunteer will also have to be in a position to be fully admitted for close monitoring from day 7 to day 17 of the research proper.

The study treatment will be administered without any charges and the subsequent monitoring and handling of any complications that might arise will be at the full expense of the company and the research team. It is important to note that a volunteer may be discontinued when and if the research team suspects myopathy or in a case where creatine phosphokinase (CPK) levels rise markedly, or if the patient has risk factors for rhabdomyolysis. There will be compensations for participation in the research per day.

The research location will be at the ABC pharmaceuticals company main laboratory located at the Northern wing of the facility. To learn more about this research contact the company through 67789445 or -- .

This research will be conducted under the direction of Jill Melanie, pHd medical laboratory.

Thanks

Reference

FDA, (2014). CFR-Code of Federal Regulations Title 21: Protection of Human Subjects. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1&subpartNode=21:1.0.1.1.20.2