BioequivalencePhase 1NCT02637037

A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

A Phase 1 study testing dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) and dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon) in people with Bioequivalence and Fixed Dose Combination Tablets, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
What is being tested?: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao) and dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 21 Dec 2015to 7 Apr 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male and female subjects aged 18 - 55 years with suitable veins for cannulation or repeated venipuncture
Females must have a negative serum pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Post-menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle-stimulating hormone (FSH) levels in the post-menopausal range
Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation
Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at screening

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator
Any clinically significant abnormal findings in vital signs, as judged by the investigator
Any clinically significant abnormalities on 12-lead ECG as judged by the investigator

Show all 19Show fewer

Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) antibody
Known or suspected history of drug abuse, as judged by the investigator
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to dapagliflozin/metformin XR.
Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening
Positive screen for drugs of abuse, cotinine or alcohol at screening or on each admission to the study center
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP
Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life
Known or suspected history of alcohol abuse or excessive intake of alcohol as judged by the investigator
Involvement of any AstraZeneca or study site employee or their close relatives
Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants in Healthy Subjects Under Fasting and Fed Conditions

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Read the detailed description

This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)

Conditions: Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
Being tested: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon), dapagliflozin/metformin XR 5/500 mg reference drug (Humacao), dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon), dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Keywords: dapagliflozin/metformin XR 5/500 mg, dapagliflozin/metformin XR10/1000 mg, bioequivalence, fixed dose combination tablets, pharmacokinetic, type 2 Diabetes Mellitus (T2DM), safety
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)Drug
single fixed-combination dose tablets
dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)Drug
single fixed-dose combination tablets
dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)Drug
single fixed-dose combination tablets
dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)Drug
single fixed-dose combination tablets

Study groups in NCT02637037
Study group	Role	What they receive
Treatment A	Experimental	Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose Receives: Drug: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)
Treatment B	Active comparator	Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose Receives: Drug: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)
Treatment C	Experimental	Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose Receives: Drug: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)
Treatment D	Active comparator	Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose Receives: Drug: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)
Treatment E	Experimental	Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose Receives: Drug: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
Treatment F	Active comparator	Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose Receives: Drug: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)
Treatment G	Experimental	Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose Receives: Drug: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)
Treatment H	Active comparator	Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose Receives: Drug: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state.
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period

Secondary outcomes (4)

Time to Reach Maximum Plasma Concentration (t Max)
To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz]
To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F]
To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F]
To characterize and compare the pharmacokinetic profiles of dapagliflozin and metformin when administered as the 2 fixed-dose combination formulations and in the fed and fasted states.
Measured: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 20157 Apr 2016

First posted22 Dec 2015 (estimated)
Study start21 Dec 2015
Primary completion7 Apr 2016
Study completion7 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BioequivalenceStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02637037
Sponsor's protocol ID: D1691C00008
Status last verified: Mar 2018
First submitted: 15 Dec 2015
Last updated: 13 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)

All Bioequivalence trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two Part Bioequivalence Study to Compare Two Fixed Dose Combination Tablets of Dapagliflozin/Metformin XR 5/500 mg (Part 1) and 10/1000 mg (Part 2) Manufactured at Two Different Plants in Healthy Subjects Under Fasting and Fed Conditions
ClinicalTrials.gov ID: NCT02637037
Acronym / sponsor ID: D1691C00008
Conditions: Bioequivalence, Fixed Dose Combination Tablets, Healthy Male and Female Subjects
Keywords: dapagliflozin/metformin XR 5/500 mg, dapagliflozin/metformin XR10/1000 mg, bioequivalence, fixed dose combination tablets, pharmacokinetic, type 2 Diabetes Mellitus (T2DM), safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 21 Dec 2015 (actual)
Primary completion: 7 Apr 2016 (actual)
Study completion: 7 Apr 2016 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Posted 13 Mar 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a bioequivalence study to compare 2 fixed-dose combination tablets of dapagliflozin/metformin XR manufactured at 2 different plants in healthy subjects under fasting and fed conditions

Detailed description

This is a Phase 1, 2-part, open-label, randomized, 4-period, 4-treatment, crossover study in healthy subjects (males and females of non-childbearing potential)

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
Treatment A	Experimental	Drug: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose
Treatment B	Active comparator	Drug: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose
Treatment C	Experimental	Drug: dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 5/500 mg dose
Treatment D	Active comparator	Drug: dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 5/500 mg dose
Treatment E	Experimental	Drug: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose
Treatment F	Active comparator	Drug: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)Under fed conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose
Treatment G	Experimental	Drug: dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR test drug (Mount Vernon) 10/1000 mg dose
Treatment H	Active comparator	Drug: dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)Under fasted conditions, subjects will receive single doses of dapagliflozin/metformin XR reference drug (Humacao) 10/1000 mg dose

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures
Healthy male and female subjects aged 18 - 55 years with suitable veins for cannulation or repeated venipuncture
Females must have a negative serum pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive at screening

Key exclusion criteria (19 listed)

History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product
Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator
Any clinically significant abnormal findings in vital signs, as judged by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)single fixed-combination dose tablets	Drug	Treatment A, Treatment C
dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)single fixed-dose combination tablets	Drug	Treatment B, Treatment D
dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)single fixed-dose combination tablets	Drug	Treatment E, Treatment G
dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)single fixed-dose combination tablets	Drug	Treatment F, Treatment H

Primary outcome

Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state.
AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state
Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
To evaluate the Bioequivalence for Dapagliflozin and Metformin following administration Dapagliflozin/Metformin XR 5/500 mg and 10/1000 mg Manufactured at Mt. Vernon plant, US, Compared to Humacao plant, Puerto Rico, in the Fasted or Fed state

4 secondary outcomes

Time to Reach Maximum Plasma Concentration (t Max)
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve [t½λz]
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC [CL/F]
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period
Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration [Vz/F]
Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period

Results and safety

Results posted to the registry on 13 Mar 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1	40	36
Part 2	40	39

Primary outcome: Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State

Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Treatment A n = 40	Treatment B n = 38	Treatment C n = 37	Treatment D n = 36	Treatment E n = 37	Treatment F n = 39	Treatment G n = 39	Treatment H n = 39
Dapagliflozin	236.3 (21.06)	248.6 (20.79)	251.6 (21.20)	258.2 (18.35)	471.9 (27.46)	486.9 (26.47)	504.4 (27.22)	516.6 (27.15)
Metformin	5484 (24.69)	5465 (27.87)	4398 (29.41)	4460 (29.69)	8403 (27.90)	8015 (31.65)	7727 (30.82)	7578 (35.76)

Treatment A vs Treatment B: Ratios of Geometric means: 0.96 (90% CI 0.93 to 0.99)
Treatment C vs Treatment D: Ratios of Geometric means: 0.99 (90% CI 0.96 to 1.01)
Treatment E vs Treatment F: Ratios of Geometric means: 0.97 (90% CI 0.94 to 1.00)

Population analysed: PK Analysis Set: All subjects in the safety analysis set for whom at least one of the primary PK parameters could be calculated for at least one analyte (dapagliflozin or metformin), and who had no major protocol deviations thought to impact on analysis of the PK data.

Primary outcome: AUC From Time Zero to Time of Last Quantifiable Concentration [AUC (0-t)] Under Fasted or Fed State.

Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Treatment A n = 40	Treatment B n = 38	Treatment C n = 37	Treatment D n = 36	Treatment E n = 39	Treatment F n = 40	Treatment G n = 39	Treatment H n = 39
Dapagliflozin	228.1 (20.43)	239.1 (21.10)	243.4 (20.93)	248.8 (17.92)	454.7 (27.15)	472.1 (26.72)	490.9 (27.30)	505.1 (26.80)
Metformin	5307 (26.54)	5205 (28.59)	4211 (28.71)	4212 (27.22)	8040 (27.82)	7798 (32.77)	7456 (30.57)	7401 (34.75)

Treatment A vs Treatment B: Ratios of Geometric means: 0.96 (90% CI 0.94 to 0.99)
Treatment C vs Treatment D: Ratios of Geometric means: 0.99 (90% CI 0.97 to 1.02)
Treatment E vs Treatment F: Ratios of Geometric means: 0.96 (90% CI 0.93 to 0.98)

Primary outcome: Observed Maximum Plasma Concentration [Cmax] Under Fasted or Fed State

Time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment A n = 40	Treatment B n = 38	Treatment C n = 37	Treatment D n = 36	Treatment E n = 39	Treatment F n = 40	Treatment G n = 39	Treatment H n = 39
Dapagliflozin	39.69 (26.42)	41.33 (18.49)	65.28 (25.49)	67.41 (24.95)	87.48 (30.14)	90.14 (32.09)	125.6 (30.77)	132.7 (28.31)
Metformin	510.2 (22.23)	503.4 (22.16)	563.2 (30.27)	573.9 (28.55)	982.6 (28.11)	975.5 (27.89)	1016 (35.36)	998.5 (36.05)

Treatment A vs Treatment B: Ratios of Geometric means: 0.98 (90% CI 0.93 to 1.03)
Treatment C vs Treatment D: Ratios of Geometric means: 0.97 (90% CI 0.90 to 1.06)
Treatment E vs Treatment F: Ratios of Geometric means: 0.97 (90% CI 0.89 to 1.05)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening until 72 hours postdose for each treatment period (ie. visit 1 to visit 6).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 40 (0%)	2 of 40 (5%)	Not reported
Treatment B	0 of 38 (0%)	5 of 38 (13.2%)	Not reported
Treatment C	0 of 37 (0%)	1 of 37 (2.7%)	Not reported
Treatment D	0 of 36 (0%)	2 of 36 (5.6%)	Not reported
Treatment E	0 of 39 (0%)	2 of 39 (5.1%)	Not reported
Treatment F	0 of 40 (0%)	4 of 40 (10%)	Not reported
Treatment G	0 of 39 (0%)	4 of 39 (10.3%)	Not reported
Treatment H	0 of 39 (0%)	3 of 39 (7.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Bioequivalence

Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
Healthy Subjects (HS)
Active, not recruitingPhase 1
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ronald Goldwater, MDCM, M.Sc, CPI principal investigator

PAREXEL Early Phase Clinical Unit Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Plasma Concentration-time Curve [AUC] Under Fasted or Fed State (time frame: Days 1 to 3: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours post-dose for each treatment period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02637037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.