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...
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