HealthyPhase 1NCT02102932

Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers

A Phase 1 study testing 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin and 850 mg metformin in people with Healthy, run by Boehringer Ingelheim at 1 site in China.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin and 850 mg metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteChina
Study dates: May 2014to Aug 2014
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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and female subjects

Who cannot join

Any relevant deviation from healthy conditions

Trial locations and contacts

1 site in 1 country.

China1 site

1276.23.86002 Boehringer Ingelheim Investigational Site
Beijing

Other trials in China

About this study

Official title: Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Conditions: Healthy
Being tested: 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin, 850 mg metformin, 5 mg empagliflozin, 12.5 mg empagliflozin/850 mg metformin FDC

What participants receive

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

5 mg empagliflozin/850 mg metformin FDCDrug
5 mg empagliflozin/850 mg metformin FDC
12.5 mg empagliflozinDrug
10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet
12.5 mg empagliflozinDrug
10mg empagliflozin tablet and 2.5 mg empagliflozin tablet
850 mg metforminDrug
850mg metformin tablet
5 mg empagliflozinDrug
5 mg empagliflozin
5 mg empagliflozinDrug
5 mg empagliflozin
850 mg metforminDrug
850 mg metformin
12.5 mg empagliflozin/850 mg metformin FDCDrug
12.5 mg empagliflozin/850 mg metformin FDC
12.5 mg empagliflozin/500 mg metformin FDCDrug
12.5 mg empagliflozin/500 mg metformin FDC
5 mg empagliflozin/500 mg metformin FDCDrug
5 mg empagliflozin/500 mg metformin FDC
500 mg metforminDrug
500 mg metformin
500 mg metforminDrug
500 mg metformin

Study groups in NCT02102932
Study group	Role	What they receive
12.5 mg empagliflozin/850 mg metformin	Experimental	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order Receives: Drug: 12.5 mg empagliflozin; Drug: 850 mg metformin; Drug: 12.5 mg empagliflozin/850 mg metformin FDC
5 mg empagliflozin/850 mg metformin	Experimental	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order Receives: Drug: 5 mg empagliflozin/850 mg metformin FDC; Drug: 5 mg empagliflozin; Drug: 850 mg metformin
12.5 mg empagliflozin/500 mg metformin	Experimental	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order Receives: Drug: 12.5 mg empagliflozin; Drug: 12.5 mg empagliflozin/500 mg metformin FDC; Drug: 500 mg metformin
5 mg empagliflozin/500 mg metformin	Experimental	24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order Receives: Drug: 5 mg empagliflozin; Drug: 5 mg empagliflozin/500 mg metformin FDC; Drug: 500 mg metformin

What is being measured

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

AUC(0-∞) for Empagliflozin
Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-∞) for Metformin
Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax for Empagliflozin
Maximum measured concentration of the empagliflozin in plasma
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Cmax for Metformin
Maximum measured concentration of the metformin in plasma
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Secondary outcomes (2)

AUC(0-tz) of Empagliflozin
Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 up to the last quantifiable data point
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-tz) of Metformin
Area under the concentration-time curve of the metformin in plasma over the time interval from 0 up to the last quantifiable data point
Measured: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Timeline

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

May 2014Aug 2014

First posted3 Apr 2014 (estimated)
Study startMay 2014
Primary completionAug 2014
Study completionAug 2014

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 HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02102932
Sponsor's protocol ID: 1276.23
Status last verified: Aug 2015
First submitted: 31 Mar 2014
Last updated: 24 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study
ClinicalTrials.gov ID: NCT02102932
Acronym / sponsor ID: 1276.23
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: May 2014
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 3 Apr 2014 (estimated)
Results: Posted 24 Sep 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
12.5 mg empagliflozin/850 mg metformin	Experimental	Drug: 12.5 mg empagliflozin, Drug: 850 mg metformin, Drug: 12.5 mg empagliflozin/850 mg metformin FDC24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/850 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 850 mg metformin tablets single dose in randomized order
5 mg empagliflozin/850 mg metformin	Experimental	Drug: 5 mg empagliflozin/850 mg metformin FDC, Drug: 5 mg empagliflozin, Drug: 850 mg metformin24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/850 mg metformin and single Empagliflozin(5mg) and metformin (850mg) tablets single dose in randomized order
12.5 mg empagliflozin/500 mg metformin	Experimental	Drug: 12.5 mg empagliflozin, Drug: 12.5 mg empagliflozin/500 mg metformin FDC, Drug: 500 mg metformin24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 12.5 mg empagliflozin/500 mg metformin and single 10 mg empagliflozin, 2.5 mg empagliflozin, 500 mg metformin tablets single dose in randomized order
5 mg empagliflozin/500 mg metformin	Experimental	Drug: 5 mg empagliflozin, Drug: 5 mg empagliflozin/500 mg metformin FDC, Drug: 500 mg metformin24 subjects (12 male and 12 female) will be assigned to 2 treatment sequences. cross-over design was adopted to ensure each patient would take fixed dose combination tablets of 5 mg empagliflozin/500 mg metformin and single Empagliflozin(5mg) and metformin (500mg) tablets single dose in randomized order

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy male and female subjects

Key exclusion criteria (1 listed)

Any relevant deviation from healthy conditions

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
5 mg empagliflozin/850 mg metformin FDC5 mg empagliflozin/850 mg metformin FDC	Drug	5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozin10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet	Drug	12.5 mg empagliflozin/500 mg metformin
12.5 mg empagliflozin10mg empagliflozin tablet and 2.5 mg empagliflozin tablet	Drug	12.5 mg empagliflozin/850 mg metformin
850 mg metformin850mg metformin tablet	Drug	12.5 mg empagliflozin/850 mg metformin
5 mg empagliflozin5 mg empagliflozin	Drug	5 mg empagliflozin/850 mg metformin
5 mg empagliflozin5 mg empagliflozin	Drug	5 mg empagliflozin/500 mg metformin
850 mg metformin850 mg metformin	Drug	5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozin/850 mg metformin FDC12.5 mg empagliflozin/850 mg metformin FDC	Drug	12.5 mg empagliflozin/850 mg metformin
12.5 mg empagliflozin/500 mg metformin FDC12.5 mg empagliflozin/500 mg metformin FDC	Drug	12.5 mg empagliflozin/500 mg metformin
5 mg empagliflozin/500 mg metformin FDC5 mg empagliflozin/500 mg metformin FDC	Drug	5 mg empagliflozin/500 mg metformin
500 mg metformin500 mg metformin	Drug	12.5 mg empagliflozin/500 mg metformin
500 mg metformin500 mg metformin	Drug	5 mg empagliflozin/500 mg metformin

Primary outcome

AUC(0-∞) for Empagliflozin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of the empagliflozin in plasma over the time interval from 0 extrapolated to infinity
AUC(0-∞) for Metformin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of the metformin in plasma over the time interval from 0 extrapolated to infinity
Cmax for Empagliflozin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of the empagliflozin in plasma
Cmax for Metformin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of the metformin in plasma

2 secondary outcomes

AUC(0-tz) of Empagliflozin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
AUC(0-tz) of Metformin
Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration

Results and safety

Results posted to the registry on 24 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T1R1	12	12
R1T1	12	12
T2R2	12	12
R2T2	12	12
T3R3	12	12
R3T3	12	12
T4R4	12	12
R4T4	12	12

Primary outcome: AUC(0-∞) for Empagliflozin

Time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: nmol * h/L

Measure	T1 (FDC) n = 24	R1 (FC) n = 24	T2 (FDC) n = 24	R2 (FC) n = 24	T3 (FDC) n = 24	R3 (FC) n = 24	T4 (FDC) n = 24	R4 (FC) n = 24
Value	4330 (16.6)	4110 (15.3)	1680 (22.0)	1630 (21.1)	4200 (20.3)	4060 (18.6)	1610 (16.5)	1560 (17.7)

T1 (FDC) vs R1 (FC): Ratio of the geometric means: 105.29 (90% CI 101.92 to 108.78), p = 0.0000, ANOVA
T2 (FDC) vs R2 (FC): Ratio of the geometric means: 103.23 (90% CI 99.91 to 106.65), p = 0.0000, ANOVA
T3 (FDC) vs R3 (FC): Ratio of the geometric means: 103.56 (90% CI 99.73 to 107.54), p = 0.0000, ANOVA

Population analysed: Pharmacokinetic set (PKS): The PKS included all evaluable subjects of the TS who provided at least 1 observation for at least 1 primary PK endpoint in both treatment periods without Important protocol violations (IPV) relevant to the evaluation of PK.

Primary outcome: AUC(0-∞) for Metformin

Measure	T1 (FDC) n = 24	R1 (FC) n = 24	T2 (FDC) n = 24	R2 (FC) n = 24	T3 (FDC) n = 24	R3 (FC) n = 24	T4 (FDC) n = 24	R4 (FC) n = 24
Value	11600 (18.9)	11100 (17.4)	11700 (21.8)	11000 (24.0)	7800 (18.9)	7510 (17.8)	7030 (20.7)	7340 (18.8)

T1 (FDC) vs R1 (FC): Ratio of the geometric means: 104.56 (90% CI 97.56 to 112.07), p = 0.0001, ANOVA
T2 (FDC) vs R2 (FC): Ratio of the geometric means: 105.80 (90% CI 99.32 to 112.70), p = 0.0001, ANOVA
T3 (FDC) vs R3 (FC): Ratio of the geometric means: 103.75 (90% CI 98.18 to 109.63), p = 0.0000, ANOVA

Primary outcome: Cmax for Empagliflozin

Measure	T1 (FDC) n = 24	R1 (FC) n = 24	T2 (FDC) n = 24	R2 (FC) n = 24	T3 (FDC) n = 24	R3 (FC) n = 24	T4 (FDC) n = 24	R4 (FC) n = 24
Value	644 (18.2)	605 (15.3)	263 (17.7)	237 (20.7)	569 (22.1)	561 (25.3)	228 (16.4)	221 (22.2)

T1 (FDC) vs R1 (FC): Ratio of the geometric means: 106.44 (90% CI 100.44 to 112.80), p = 0.0000, ANOVA
T2 (FDC) vs R2 (FC): Ratio of the geometric means: 110.78 (90% CI 103.80 to 118.24), p = 0.0021, ANOVA
T3 (FDC) vs R3 (FC): Ratio of the geometric means: 101.38 (90% CI 94.82 to 108.39), p = 0.0000, ANOVA

Primary outcome: Cmax for Metformin

Measure	T1 (FDC) n = 24	R1 (FC) n = 24	T2 (FDC) n = 24	R2 (FC) n = 24	T3 (FDC) n = 24	R3 (FC) n = 24	T4 (FDC) n = 24	R4 (FC) n = 24
Value	1920 (20.9)	1830 (16.6)	1950 (26.4)	1840 (26.0)	1290 (22.2)	1230 (27.1)	1150 (25.5)	1190 (21.3)

T1 (FDC) vs R1 (FC): Ratio of the geometric means: 104.91 (90% CI 99.29 to 110.86), p = 0.0000, ANOVA
T2 (FDC) vs R2 (FC): Ratio of the geometric means: 106.32 (90% CI 98.39 to 114.88), p = 0.0008, ANOVA
T3 (FDC) vs R3 (FC): Ratio of the geometric means: 104.44 (90% CI 96.68 to 112.82), p = 0.0003, ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First drug administration until 7 days after last drug administration, up to 8 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T1 (FDC)	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
R1 (FC)	0 of 24 (0%)	8 of 24 (33.3%)	Not reported
T2 (FDC)	0 of 24 (0%)	9 of 24 (37.5%)	Not reported
R2 (FC)	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
T3 (FDC)	0 of 24 (0%)	12 of 24 (50%)	Not reported
R3 (FC)	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
T4 (FDC)	0 of 24 (0%)	7 of 24 (29.2%)	Not reported
R4 (FC)	0 of 24 (0%)	9 of 24 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin and 850 mg metformin in people with Healthy, run by Boehringer Ingelheim at 1 site in China.

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 1 inclusion and 1 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 24 Sep 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 China. 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 24 Sep 2015). 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?

AUC(0-∞) for Empagliflozin (time frame: 1 hour (h) before drug administration and 20 min (m), 40m, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration). The study lists 4 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 NCT02102932.

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 24 Sep 2015.