A clinical drug trial is conducting a study of pharmacokinetics and safety of a drug in healthy individuals. The nurse will assist enrollment of participants into the next phase of the study and will include which subject?
Healthy and ill subjects
Subjects with other diseases
Subjects with disease the drug will treat
Healthy subjects
The Correct Answer is C
A. Phase I trials focus on healthy individuals, but the next phase (Phase II) involves patients with the target disease. Including both healthy and ill subjects at this stage is not appropriate.
B. Subjects with other diseases are not included in Phase II trials because the goal is to test the drug in individuals who have the specific condition the drug is intended to treat.
C. Phase II clinical trials focus on evaluating the drug’s efficacy and safety in individuals who have the disease it is designed to treat. This phase helps determine the optimal dosage and potential side effects in the target population.
D. Healthy subjects are included in Phase I trials to assess safety and pharmacokinetics, but in the next phase (Phase II), the study shifts to testing the drug in patients with the disease it is meant to treat.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is C
Explanation
a) Clarifying the order with the charge nurse is not the correct action. The charge nurse may not be able to clarify medication orders and is not the primary contact for this issue.
b) Diluting and administering the medication by gastrostomy tube (GT) is inappropriate because the medication is ordered to be taken p.o. (by mouth), not via the tube.
c) Clarifying the order with the healthcare provider is the most appropriate step. A p.o. order is typically for oral administration, but the client has a gastrotomy tube. The nurse should clarify with the provider whether the medication can be crushed and administered via the tube or if a different route or medication form is necessary.
d) Administering the medication p.o. as ordered would not be appropriate if the client is unable to take oral medications. The nurse should verify the appropriate route of administration based on the patient's condition.
Correct Answer is C
Explanation
A. The statement that no drug remains is incorrect. A drug with a half-life of 8 hours will not be completely eliminated in 24 hours, as it follows a predictable pattern of reduction.
B. A reduction to 50 mg would require additional half-life intervals beyond 24 hours. The drug concentration decreases by half every 8 hours, meaning it would take more than 24 hours to reach this level.
C. The correct calculation follows the half-life principle:
- At 8 hours: 800 mg → 400 mg
- At 16 hours: 400 mg → 200 mg
- At 24 hours: 200 mg → 100 mg
Therefore, 100 mg of the drug remains after 24 hours.
D. While 200 mg is a step in the process, it represents the amount remaining after only 16 hours, not the full 24-hour period.
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