Bioequivalence and Bioavailability Forum

velupharm ☆ 2006-09-18 10:22 (6809 d 09:36 ago) Posting: # 251 Views: 8,601	Intake of another drug during study period [Outliers] Post reply
	Dear group we did a BE study with sertraline.During the washout period one of the volunteers took two tablets of acetaminophen500mg. Now whether this volunteer should be withdrawn from the study or should be continued and an appropriate justification can be given later?. (no literature was showing a PK interaction between both these drugs)

chintan98 ● 2006-09-21 14:32 (6806 d 05:27 ago) @ velupharm Posting: # 252 Views: 7,075	Intake of another drug during study period Post reply
	If acetaminophen is having no interaction with you study drugs, there is no need to withdraw the subject. Because acetaminophen will not affect the PK profile of the study drug. Chintan Mehta

Helmut
★★★

Vienna, Austria,
2006-09-21 14:50
(6806 d 05:08 ago)

@ velupharm
Posting: # 253
Views: 6,914

Intake of another drug during study period

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Dear velupharm,

I agree with Chintan's answer.
Don't forget to refer it together with your justification of keeping the subject in the study (lacking interaction) in sections 10.2 & 16.2.2 of the clinical study report.

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Helmut Schütz

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Intake of another drug during study period [Outliers]

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Intake of another drug during study period