Trials Sponsors Conditions Drugs Pricing

Conditions

diabetes

Outcome Measures

Primary Outcomes (2)

Cmax
AUC0-t

Secondary Outcomes (6)

AUC0-inf
AUC_%Extrap
AUC0-t/AUC0-∞
Tmax
Kel
+1 more secondary outcomes

Interventions

Dapagliflozin tablets 10 mgType not reported

Forxiga 10 mg film-coated tabletsType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Dapagliflozin tablets 10 mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
Forxiga 10 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Dapagliflozin tablets 10 mg
Named ingredient: dapagliflozin
View registry record
Forxiga 10 mg film-coated tablets
Named ingredient: dapagliflozin
View registry record

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or female volunteer with age between 18-45 years, inclusive
Non-vegetarian diet habit

Sponsors & Collaborators

Sun Pharmaceutical Industries Limited
Industrylead

Study Sites (1)

Terapia S.A.

Cuj-Napoca, 400632, Romania

Adriana Marcovici+40264501121 adriana.marcovici@sunpharma.com

Central Study Contacts

Arshad Khuroo

+911244768005 Arshad.Khuroo@sunpharma.com

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

July 19, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2023-506408-18-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 03:54:18 UTC

Documents

Summary of results DAPAG-02-23_redacted

You may not qualify if:

History of allergic reactions to dapagliflozin or oral antidiabetes drugs
Presence or history of symptomatic episodes of hypoglycemia (e.g. sweating, malaise, tachycardia, dizziness, loss of consciousness, nervousness) confirmed as hypoglycemia-by a glucometer or blood test in the last year
History of any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis)
History of hypertension/hypotension or presence of persistent values measured in sitting position for systolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg or for systolic blood pressure <90 mmHg and diastolic blood pressure <60 mmHg
History or presence of clinically significant gastrointestinal, hepatic, renal disease or any other condition known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Positive for HIV 1 or 2, Hepatic B or C viruses markers or syphilis infection
Clinically significant abnormalities in the laboratory results, as judged by the investigator
Clinical important abnormalities in rhythm, conduction or morphology of the ECG that may interfere with the volunteer’s safety
History or presence of clinically significant cardiovascular, respiratory, neurological, reproductive, musculoskeletal, lymphatic, hematological disease, diabetes/impaired glucose tolerance, systemic disorders (immunological and connective tissue) or any other disorder that in the opinion of the investigator may jeopardize the volunteer’s safety or influence the results of the study
History of any psychiatric illness
Regular smokers who smoke more than 5 cigarettes daily
History of drug dependence or alcohol intake on a habitual basis of more than 2 units of alcohol per day (1 unit alcohol equivalent to 500 mL beer; 200 mL wine; 50 mL distilled drinks)
Use of any pharmacological agent or dietary product known to induce the study drug metabolism within 28 days prior to the dosing day of this study or any pharmacological agent or dietary product known to inhibit the study drug metabolism within 14 days prior to the dosing day of this study
Use any Investigational Medicinal Product in a clinical trial within 12 weeks prior to the dosing day of this study
Donation or significant blood loss (400 mL or more) within 12 weeks prior to the dosing day of the study
+3 more criteria

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations