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A Single Center, Open Label, Randomized, Single-dose, Two-period, Two-way Cross-over Study to Compare the Rate and Extent of Absorption of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects

ClinicalTrials.gov · COMPLETED, 2022

60 participants

Abstract

Single oral dose of study drug in two period(s) separated by a washout period of seven (07) days. Blood samples will be taken up to 24.0 hours post-dose.

Conditions: Healthy, Bioequivalence Study.

Primary outcome: Cmax; Tmax; AUC.

Enrollment: 60 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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