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Bioequivalence Study of DelanzoᵀᴹDR 60mg (Dexlansoprazole) Capsule With Dexilant® 60mg (Dexlansoprazole) Capsule in Healthy Pakistani Subjects.

NCT04877834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-29

No results posted yet for this study

Summary

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

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.

DRUG

Dexlansoprazole

Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.

Sponsors & Collaborators

  • SAMI Pharmaceutical, Karachi Pakistan

    collaborator UNKNOWN

  • University of Karachi

    lead OTHER

Principal Investigators

  • Prof. Dr. Muhammad R Shah, PhD · Center for bio-equivalence, and clinical research, university of karachi

  • Dr. Naghma Hashmi (Co-PI), PhD · Center for bio-equivalence, and clinical research, university of karachi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-18
Primary Completion
2022-10-25
Completion
2022-11-25

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877834 on ClinicalTrials.gov