Type 2 Diabetes MellitusPhase 1NCT01535677

To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately

A Phase 1 study testing Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted and Dapagliflozin + Glucophage tablet fed in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United Kingdom.

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 an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted and Dapagliflozin + Glucophage tablet fed
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2013to Jul 2013
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy volunteers aged 18 to 55 years inclusive with suitable veins for cannulation or repeated vein puncture
Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
Non-pregnant, non-lactating female subjects who if pre-menopausal are using adequate birth control eg, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device (IUD)/intrauterine systems
Have a body mass index (BMI) between 18.5 and 30.0 kg/m2 inclusive (ie, within 15% of normal range) and weigh at least 50 kg and no more than 100 kg.

Who cannot join

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 important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with individual safety evaluation Current smokers who smoke more than 5 cigarettes per day (or equivalent use of tobacco products) or cannot give up smoking during the study
Excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day)
Plasma donation within one month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Read the detailed description

A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5.0 mg/850 mg) Relative to a 5.0 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Conditions: Type 2 Diabetes Mellitus
Being tested: Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted, Dapagliflozin + Glucophage tablet fed, Dapagliflozin/metformin IR FDC tablet fed
Keywords: Phase 1, healthy volunteers, cross-over study, Bioavailability, Bioequivalence, Cmax, tmax, AUC, AUC(0-t), λz, tlast
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 + Glucophage tablet fastedDrug
Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state
Dapagliflozin/metformin IR FDC tablet fastedDrug
single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state
Dapagliflozin + Glucophage tablet fedDrug
Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state
Dapagliflozin/metformin IR FDC tablet fedDrug
single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state

Study groups in NCT01535677
Study group	Role	What they receive
1	Experimental	5 mg dapagliflozin and 850 mg Glucophage in fasted state Receives: Drug: Dapagliflozin + Glucophage tablet fasted
2	Experimental	dapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted Receives: Drug: Dapagliflozin/metformin IR FDC tablet fasted
3	Experimental	5 mg dapagliflozin and 850 mg Glucophage in fed state Receives: Drug: Dapagliflozin + Glucophage tablet fed
4	Experimental	dapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state Receives: Drug: Dapagliflozin/metformin IR FDC tablet fed

What is being measured

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

Area under the curve over the time (AUC)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t))
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Maximum concentration (Cmax)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose

Secondary outcomes (14)

Time to reach maximum analyte concentration (tmax)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Terminal rate constant (λz)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Time of last quantifiable analyte concentration (tlast)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Terminal half-life (t1/2)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Observed maximum analyte concentration (Cmax)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t))
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Elimination terminal half-life (t1/2)
No statistical analysis will be performed
Measured: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Safety profile description in term of Adverse Events
No statistical analysis will be performed
Measured: from first dose in treatment period 1 up to 10 days after final dose
Safety profile description in term of Blood Pressure
No statistical analysis will be performed
Measured: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Physical Examination
No statistical analysis will be performed
Measured: at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose
Safety profile description in term of Electrocardiogram ECG
No statistical analysis will be performed
Measured: at screening and up to 10 days after final dose
Safety profile description in term of Heart Rate
No statistical analysis will be performed
Measured: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Safety Labs
No statistical analysis will be performed
Measured: at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose

Timeline

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

Apr 2013Jul 2013

First posted20 Feb 2012 (estimated)
Study startApr 2013
Primary completionJul 2013
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies 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: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01535677
Sponsor's protocol ID: D1691C00007
Status last verified: Jul 2015
First submitted: 13 Jan 2012
Last updated: 9 Jul 2015
Results posted: No

Publications

Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW. Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004. Epub 2015 Jun 3.
PubMed 26048185

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?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
ClinicalTrials.gov ID: NCT01535677
Acronym / sponsor ID: D1691C00007
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1, healthy volunteers, cross-over study, Bioavailability, Bioequivalence, Cmax, tmax, AUC
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Bristol-Myers Squibb
Study start: Apr 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 20 Feb 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Dapagliflozin + Glucophage tablet fasted5 mg dapagliflozin and 850 mg Glucophage in fasted state
2	Experimental	Drug: Dapagliflozin/metformin IR FDC tablet fasteddapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted
3	Experimental	Drug: Dapagliflozin + Glucophage tablet fed5 mg dapagliflozin and 850 mg Glucophage in fed state
4	Experimental	Drug: Dapagliflozin/metformin IR FDC tablet feddapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy volunteers aged 18 to 55 years inclusive with suitable veins for cannulation or repeated vein puncture
Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
Non-pregnant, non-lactating female subjects who if pre-menopausal are using adequate birth control eg, oral, injectable, transdermal or implanted hormonal contraceptives, vaginal contraceptive ring, intrauterine device (IUD)/intrauterine systems
Have a body mass index (BMI) between 18.5 and 30.0 kg/m2 inclusive (ie, within 15% of normal range) and weigh at least 50 kg and no more than 100 kg.

Key exclusion criteria (4 listed)

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 important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with individual safety evaluation Current smokers who smoke more than 5 cigarettes per day (or equivalent use of tobacco products) or cannot give up smoking during the study
Excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks and cola (more than 5 cups of coffee or equivalent per day)
Plasma donation within one month of screening or any blood donation/blood loss >500 mL during the 3 months prior to screening

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 + Glucophage tablet fastedSingle oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state	Drug	1
Dapagliflozin/metformin IR FDC tablet fastedsingle oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state	Drug	2
Dapagliflozin + Glucophage tablet fedSingle oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state	Drug	3
Dapagliflozin/metformin IR FDC tablet fedsingle oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state	Drug	4

Primary outcome

Area under the curve over the time (AUC)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
No statistical analysis will be performed
AUC from time zero to the time of last quantifiable analyte concentration (AUC(0-t))
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
No statistical analysis will be performed
Maximum concentration (Cmax)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
No statistical analysis will be performed

14 secondary outcomes

Time to reach maximum analyte concentration (tmax)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Terminal rate constant (λz)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Time of last quantifiable analyte concentration (tlast)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Terminal half-life (t1/2)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Observed maximum analyte concentration (Cmax)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUC(0 t))
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Elimination terminal half-life (t1/2)
Time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose
Safety profile description in term of Adverse Events
Time frame: from first dose in treatment period 1 up to 10 days after final dose
Safety profile description in term of Blood Pressure
Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Physical Examination
Time frame: at screening, Day -1 and Day 4 at Visits 2 to 5 and up to 10 days after final dose
Safety profile description in term of Electrocardiogram ECG
Time frame: at screening and up to 10 days after final dose
Safety profile description in term of Heart Rate
Time frame: at screening, once daily during the residential period (5 days each) and up to 10 days after final dose
Safety profile description in term of Safety Labs
Time frame: at screening, on Day -1 and Day 4 (72 hours post-dose) at Visits 2 to 5 and up to 10 days after final dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
Results publication: PubMed 26048185Chang M, Liu X, Cui D, Liang D, LaCreta F, Griffen SC, Lubin S, Quamina-Edghill D, Boulton DW. Bioequivalence, Food Effect, and Steady-State Assessment of Dapagliflozin/Metformin Extended-release Fixed-dose Combination Tablets Relative to Single-component Dapagliflozin and Metformin Extended-release Tablets in Healthy Subjects. Clin Ther. 2015 Jul 1;37(7):1517-28. doi: 10.1016/j.clinthera.2015.05.004. Epub 2015 Jun 3.
D1691C00007\_CSR\_SynopsisLink provided by the sponsor.
D1691C00007\_Clinical\_Study\_ProtocolLink provided by the sponsor.

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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.

Eva Johnsson, MD study director

AstraZeneca Research and Development SE-431 83 Mölndal Sweden

Saeed Kahn, MBBS principal investigator

Quintiles Drug Research Unit at Guy's Hospital, 6 Newcomen St, London SE1 1YR

Mirjana Kujacic, PHD study chair

AstraZeneca Research and DevelopmentSE-431 83 Mölndal Sweden

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 4 inclusion and 4 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 9 Jul 2015. 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 Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 the curve over the time (AUC) (time frame: pre-dose, 0.25 min, 0.5 min, 1h, 1.5h, 2 h, 3h , 4 h, 5 h , 6 h, 8 h, 10 h, 12 h, 16 h, 24 h, 30 h, 36 h, 42 h, 48 h, 54 h, 60 h and 72 h post-dose). 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 NCT01535677, which also lists 1 linked publication.

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 9 Jul 2015.