Ethics and Evidence in Clinical Trials
Healthy participants will be assigned to group A and B. subjects in group A were given 50mg of JP234 from day 3 to day 10 and warfarin 1.5 mg from day 7 to day 14. Participants in group 2 will receive 1.5 mg of warfarin from day 3 to 10 and then 50mgs once a day from day 7 to 14. Both drugs will be administered for the first fourteen days while the remaining six days will be utilized as the washout period. Plasma levels of the drugs will be assessed in both groups. Monitoring plasma concentration is essential in drug interaction studies. The subjects will be closely monitored for heart activity, clotting factor level, and heart rate through the utilization of an electrocardiogram. The drug is believed to be well tolerated during clinical trials and has less contraindication association with it (Simon, 2007). The result of the finding will be utilized in identifying the action of the new drug on the metabolism of warfarin. Through blood sample study and the hearts activity measure, the effectiveness and the action of JP234 on warfarin will be measured. The study aims at finding out the effect of JP234 on the action of warfarin. Any changes in the participants will be recorded. Tolerability and the safety of the drug will be assessed too. JP234 is well tolerated during clinical trials and there is no contradiction associated with it. The drug when administered is effective in doses of 50, 75 or 100mg once daily. The drug is metabolized in the liver and has a half-life of about 24 hours. In vitro studies indicate that the drug can induce CYP2C9. Patients with chronic atrial fibrillation should be anticoagulated to hinder thromboembolism from taking place (Goodman, 2005). Patient taking JP234 are recommended to take warfarin that is partly metabolized by CYP2C9. JP234 is an antiarrhythmic drug and is usually excreted in the liver just the same as warfarin.