consume at home. Because we are measuring iron in serum after an iron tablet is taken, diet control is required to stabilise levels before dosing. Subjects will be housed at the Zenith Clinical Site for 12 hours prior to dosing until 24 hours after dosing in each of the two study periods. The blood sample at 36 hours will be collected by venepuncture at Zenith Technology. During the two treatment periods, each subject will receive a single dose of either formulation according to the dosing schedule. Subjects will receive one dose of the test formulation and one dose of the Reference formulation following an overnight fast of 10 hours. There will be at least 1 week washout between each dosing period. Blood samples will be collected at baseline (prior to dosing at -2.0 hours,-0.5 hours and 0 hours) and at specified times up to 36 hours after dosing. Serum will be assayed for total iron by using a Colorimetric method. The single-dose safety and tolerability of the formulations will also be assessed. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee asked for a justification for excluding females. The Researcher(s) explained the scientific rationale behind the exclusion. The Committee accepted this justification. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee asked about the end of the compensation clause. Please remove the two limiting statements from the compensation clause, and ensure compensation is in line with ACC, as per chapter 8 of the National Ethics Advisory Committee Guidelines for Intervention Studies. The Committee requested the following changes to the Participant Information Sheet and Consent Form: The Committee noted the participant information sheet states unused blood can be returned, on consent form states it will be destroyed please align these statements. – Decision This application was approved with non-standard conditions by consensus. 9 Ethics ref: 17/NTA/258 Title: CRACKLE II Principal Investigator: Dr David Holland Sponsor: Start Date: 30 November 2017 Dr David Holland was present in person for discussion of this application.
consume at home. Because we are measuring iron in serum after an iron tablet is taken, diet control is required to stabilise levels before dosing. Subjects will be housed at the Zenith Clinical Site for 12 hours prior to dosing until 24 hours after dosing in each of the two study periods. The blood sample at 36 hours will be collected by venepuncture at Zenith Technology. During the two treatment periods, each subject will receive a single dose of either formulation according to the dosing schedule. Subjects will receive one dose of the test formulation and one dose of the Reference formulation following an overnight fast of 10 hours. There will be at least 1 week washout between each dosing period. Blood samples will be collected at baseline (prior to dosing at -2.0 hours,-0.5 hours and 0 hours) and at specified times up to 36 hours after dosing. Serum will be assayed for total iron by using a Colorimetric method. The single-dose safety and tolerability of the formulations will also be assessed. Summary of ethical issues (resolved) The main ethical issues considered by the Committee and addressed by the Researcher are as follows. The Committee asked for a justification for excluding females. The Researcher(s) explained the scientific rationale behind the exclusion. The Committee accepted this justification. Summary of ethical issues (outstanding) The main ethical issues considered by the Committee and which require addressing by the Researcher are as follows. The Committee asked about the end of the compensation clause. Please remove the two limiting statements from the compensation clause, and ensure compensation is in line with ACC, as per chapter 8 of the National Ethics Advisory Committee Guidelines for Intervention Studies. The Committee requested the following changes to the Participant Information Sheet and Consent Form: The Committee noted the participant information sheet states unused blood can be returned, on consent form states it will be destroyed – please align these statements. Decision This application was approved with non-standard conditions by consensus. 9 Ethics ref: 17/NTA/258 Title: CRACKLE II Principal Investigator: Dr David Holland Sponsor: Start Date: 30 November 2017 Dr David Holland was present in person for discussion of this application.