Bioequivalence Study of Delanzo??DR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bioequivalence Study
- Healthy
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: A single center, open-label, randomized, single-dose, two-period, two-way, cross-over study.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
Description
Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood sampl...
Test Product DelanzoTMDR 60 mg Capsule, manufactured by SAMI Pharmaceuticals (Pvt.) Ltd.or Reference Product Dexilant® 60 mg Capsule, manufactured by Takeda Pharmaceutical Company Limited. will be administered to healthy male Pakistani volunteers with 240 mL ambient temperature water and blood samples will be taken up to 24 hours post dose for the calculation of Cmax, Tmax, AUC.
Tracking Information
- NCT #
- NCT04877834
- Collaborators
- SAMI Pharmaceutical, Karachi Pakistan
- Investigators
- Principal Investigator: Muhammad R Shah, PhD Center for bio-equivalence, and clinical research, university of karachi
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