HealthyPhase 1NCT01992211

Evaluating of Pharmacokinetic Profile of BCWP_C003 and Co-administration of Rosuvastatin and Metformin

A Phase 1 study testing Rosuvastatin, Metformin and BCWP_C003 in people with Healthy, run by BC World Pharm Co. Ltd. at 1 site in South Korea.

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

The purpose of this study is to evaluate the pharmacokinetic Profile and Safety/Tolerability of BCWP_C003 compared to Co-Administration of Crestor 10mg and Glucophage XR 1000mg, and to evaluate the food effect of Pharmacokinetic profile of BCWP_C003 after administration. Read more about this study

Who is it for?: Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rosuvastatin, Metformin and BCWP_C003
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteSouth Korea
Study dates: 15 Dec 2016to 10 Jul 2017
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 19 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Male Volunteer, age 19 to 45 years at the time of screening
Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0
Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result
Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness

Who cannot join

Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction
Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily
Subject who has family history of hereditary muscular disorder or muscular side effect
Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery)
Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration
Subject who has results of clinical laboratory test as follows :

Show all 20Show fewer

AST, ALT level exceed the normal range more than 1.5 times
Total bilirubin level exceed the normal range more than 1.5 times
Creatinine clearance under 60mL/min calculated by MDRD
In the vital sign, systolic blood pressure is more than 150mmHg, less than 90mmHg or diastolic blood pressure is more than 95mmHg, less than 50mmHg
Subject who has presence or history of drug abuse, or positive screening for drug abuse
→ Alcohol abuse defines to drink over 21 unit/week(alcohol 1unit = 10g = 12.5 mL) persistingly
Subject who participated in another clinical trial within 3 month prior to the drug administration
Subject who had taken medicine(Barbital etc) related drug metabolizing enzyme induction or inhibition within 1 month prior to the drug administration
Subject who had taken prescription drug or oriental medicine within 2 weeks or OTC drug or vitamin formulation within a week prior to the drug administration
Subject who had a diet which can affect the absorption, distribution, metabolism or elimination of Rosuvastatin/Metformin (Particulary, Grapefruit - within 48h prior to the drug administration)
Subject who donated whole blood within 2 month or component blood within 1 month prior to the drug administration
Subject who smokes more than 10 cigarettes per day
Subject who has positive HBsAg, HCV Ab or HIV Ab
Subject who is judged to be ineligible by principal investigator or sub-investigator according to various test results

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Randomized, Open, Cross-over, Single Dose Study to Evaluate the PK, Safety/Tolerability of BCWP_C003 Compared to Coadministration of Rosuvastatin and Metformin SR, and the Food Effect on the PK of BCWP_C003 in Healthy Volunteers

Read the detailed description

Clinical Trials to Evaluate the Pharmacokinetic Profiles and Safety/Tolerability of BCWP_C003 Formulation compared to Coadministration of Rosuvastatin and Metformin SR Formulation, and to Evaluate the Effect of Food on the Pharmacokinetic Profile of BCWP_C003 after Single Oral Administration to Healthy Male Subjects.

Conditions: Healthy
Being tested: Rosuvastatin, Metformin, BCWP_C003

What participants receive

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

RosuvastatinDrug
Also called Crestor 10mg(Rosuvastatin)
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
MetforminDrug
Also called Glucophage XR 1000mg(Metformin)
Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
BCWP_C003Drug
Also called Rosuvastatin and Metformin
Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.

Study groups in NCT01992211
Study group	Role	What they receive
Treatment Sequence 1(ABC)	Experimental	Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003
Treatment Sequence 2(ACB)	Experimental	Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003
Treatment Sequence 3(BAC)	Experimental	Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003
Treatment Sequence 4(BCA)	Experimental	Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003
Treatment Sequence 5(CAB)	Experimental	Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003
Treatment Sequence 6(CBA)	Experimental	Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day. Receives: Drug: Rosuvastatin; Drug: Metformin; Drug: BCWP_C003

What is being measured

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

Rosuvastatin AUClast
Rosuvastatin AUClast
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin Cmax
Rosuvastatin Cmax
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin AUClast
Metformin AUClast
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin Cmax
Metformin Cmax
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h

Secondary outcomes (8)

N-desmethyl rosuvastatin Cmax
N-desmethyl rosuvastatin Cmax
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUClast
N-desmethyl rosuvastatin AUClast
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUCinf
N-desmethyl rosuvastatin AUCinf
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
Measured: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h

Timeline

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

15 Dec 201610 Jul 2017

First posted25 Nov 2013 (estimated)
Study start15 Dec 2016
Primary completion28 Apr 2017
Study completion10 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: 6 x 3
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992211
Sponsor's protocol ID: BCWP1202_102
Status last verified: Jul 2017
First submitted: 19 Nov 2013
Last updated: 17 Jul 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: 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

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Open, Cross-over, Single Dose Study to Evaluate the PK, Safety/Tolerability of BCWP_C003 Compared to Coadministration of Rosuvastatin and Metformin SR, and the Food Effect on the PK of BCWP_C003 in Healthy Volunteers
ClinicalTrials.gov ID: NCT01992211
Acronym / sponsor ID: BCWP1202_102
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: BC World Pharm Co. Ltd.Industry (pharma, biotech, devices)
Study start: 15 Dec 2016 (actual)
Primary completion: 28 Apr 2017 (actual)
Study completion: 10 Jul 2017 (actual)
First posted: 25 Nov 2013 (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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: 6 x 3

Arm	Type	Receives
Treatment Sequence 1(ABC)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day.
Treatment Sequence 2(ACB)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day.
Treatment Sequence 3(BAC)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 15Day.
Treatment Sequence 4(BCA)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day.
Treatment Sequence 5(CAB)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 8Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 15Day.
Treatment Sequence 6(CBA)	Experimental	Drug: Rosuvastatin, Drug: Metformin, Drug: BCWP_C003Participant will be administered a single oral dose of BCWP_C003 under Fed condition on 1Day. Participant will be administered a single oral dose of BCWP_C003 under Fasting condition on 8Day. Participant will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition on 15Day.

Who may qualify

Ages: 19 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy Male Volunteer, age 19 to 45 years at the time of screening
Body weight is not less than 55kg, not more than 90kg and the result of Body Mass Index(BMI) is not less than 18.5, not more than 25.0
Subject who has no congenital, chronic disease, and no disease symptom or finding in medical examination result
Subject who comprehended the purpose, contents of the study, property of clinical drug and signed the informed consent to participate in the trial having the willingness

Key exclusion criteria (20 listed)

Subject who has history of hypersensitivity reaction for relevant drug(statin, biguanide) or clinically significant hypersensitivity reaction
Subject who has history or presence of clinically disease in liver, kidney, gastrointestinal tract, respiratory system, musculoskeletal, endocrine system, mental disorder, blood-tumor, cardiovascular. Particulary, subject who has bleeding disorder or tend to be bleeding with bruised easily
Subject who has family history of hereditary muscular disorder or muscular side effect
Subject who has history of gastrointestinal tract disorder which can affect the drug absorption or surgery(excluding appendectomy, hernia surgery)
Subject who had taken diagnosis with peptic ulcer within 2 month prior to the drug administration

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
RosuvastatinAlso: Crestor 10mg(Rosuvastatin)Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.	Drug	Treatment Sequence 1(ABC), Treatment Sequence 2(ACB), Treatment Sequence 3(BAC), Treatment Sequence 4(BCA), Treatment Sequence 5(CAB), Treatment Sequence 6(CBA)
MetforminAlso: Glucophage XR 1000mg(Metformin)Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.	Drug	Treatment Sequence 1(ABC), Treatment Sequence 2(ACB), Treatment Sequence 3(BAC), Treatment Sequence 4(BCA), Treatment Sequence 5(CAB), Treatment Sequence 6(CBA)
BCWP_C003Also: Rosuvastatin and MetforminParticipant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.	Drug	Treatment Sequence 1(ABC), Treatment Sequence 2(ACB), Treatment Sequence 3(BAC), Treatment Sequence 4(BCA), Treatment Sequence 5(CAB), Treatment Sequence 6(CBA)

Primary outcome

Rosuvastatin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin AUClast
Rosuvastatin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin Cmax
Metformin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin AUClast
Metformin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Metformin Cmax

8 secondary outcomes

N-desmethyl rosuvastatin Cmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUClast
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
N-desmethyl rosuvastatin AUCinf
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin AUCinf
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Tmax
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin t1/2
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin Vz/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h
Rosuvastatin, N-desmethyl rosuvastatin, Metformin CL/F
Time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h

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 17 Jul 2017.
Individual participant dataSharing planned: No

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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.

Kyung-Sang Yu, MD. PhD. principal investigator

Seoul National University Hospital

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 Rosuvastatin, Metformin and BCWP_C003 in people with Healthy, run by BC World Pharm Co. Ltd. at 1 site in South Korea.

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 20 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 17 Jul 2017. 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 South Korea. 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?

Rosuvastatin AUClast (time frame: pre-dose, post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24, 36, 48, 72h). 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 NCT01992211.

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 17 Jul 2017.