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Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg

NCT06233045 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-31

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 5 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Dapagliflozin-Test product

Dapagliflozin tablet 10 mg Test product Manufactured by: ZYDUS LIFESCIENCES LIMITED, India

DRUG

Dapagliflozin-Reference product

Dapagliflozin tablet 10 mg Reference product Manufactured by: ASTRAZENECA PHARMACEUTICALS LP, USA

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2024-08-25
Completion
2024-09-08

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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 NCT06233045 on ClinicalTrials.gov