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PharmacokineticsPhase 4NCT02233972

A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam

A Phase 4 study testing Midazolam and Ginkgolides Meglumine Injection in people with Pharmacokinetics, run by Jiangsu Kanion Pharmaceutical Co., Ltd 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

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing… Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Pharmacokinetics
What is being tested?
Midazolam and Ginkgolides Meglumine Injection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteChina
Study dates
Aug 2014to Oct 2014
Phase
Phase 4
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 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ages 18-40.
  • Male.
  • Subjects have standard weight( generally not less than 50 kg), and body mass index (BMI) within 19-25.
  • All physical examinations( including ECG, kidney function, liver function, blood routine, urine routines, etc) are normal.
  • Subjects have no history of significant diseases, allergy or orthostatic hypotension.
  • All subjects sign the informed consent after being informed all possible adverse drug reaction and .are able to complete all examination defined.

Who cannot join

  • Subjects who cannot communicate with medical staff, and subjects with cerebral insufficiency or psychological problem.
  • Partner of subjects have plan to pregnant.
  • Subject have primary disease in vital organ.
  • Subjects have a history of drug dependence or psychosis in last 2 years.
  • Subjects with severe blood loss or blood donation more than 200 mL in the prior 3 months.
  • Subjects who have participated in another clinical trial within the prior 3 months.
Show all 13Show fewer
  • Known or suspected to have a history of alcohol or drug abuse.
  • Subjects who have abnormal clinical significance after checking preclinical laboratory data and physical examinations.
  • Known allergy to pharmaceutical ingredient of Ginkgolides Meglumine Injection or allergy sufferers who are allergic to more than two kinds of food or drugs in the past.
  • Subjects who have used any drugs in the prior 2 weeks.
  • Subjects have unexplained infections.
  • The subjects could not complete the study in the opinion of the Principal Investigator due to any reason.
  • Subjects who test positive at screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) , hepatitis B surface antigen (HbsAg), etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: A Drug-Drug Interaction Study To Investigate The Ginkgolides Meglumine Injection To Alter The Pharmacokinetics Of Midazolam.

This is an open label, randomized, Parallel Assignment, placebo-controlled study. One of the purposes of this study is to investigate the multiple dosing Ginkgolides Meglumine Injection to alter the pharmacokinetics of Midazolam, the other is to calculate the pharmacokinetic parameters after Single and multiple dosing of Ginkgolides Meglumine Injection.

Being tested
Midazolam, Ginkgolides Meglumine Injection, placebo
Keywords
Pharmacokinetics, Ginkgolides Meglumine Injection

What participants receive

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

  • MidazolamDrug

  • Ginkgolides Meglumine InjectionDrug

  • placeboDrug

Study groups in NCT02233972
Study groupRoleWhat they receive
Midazolam and Ginkgolides Meglumine InjectionExperimentalMidazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Ginkgolides Meglumine Injection: 25mg, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
Receives: Drug: Midazolam; Drug: Ginkgolides Meglumine Injection
Midazolam and placeboPlacebo comparatorMidazolam: tablet, 7.5 mg. Midazolam will be taken on Day 1 and Day 22. Placebo: Sodium Chloride Injection, 250 ml, intravenous drip, once a day. It will be used on Day 8 -Day 21, 14 days totally.
Receives: Drug: Midazolam; Drug: placebo

What is being measured

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

  1. Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam.

    Measured: Day 1 and Day 22

  2. Pharmacokinetics parameters：AUC0-24h（Day 22/ Day 1）、Cmax（Day 22/ Day 1）for Midazolam.

    Measured: Day 1 and Day 22

  3. Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Ginkgolides Meglumine Injection.

    Measured: Day 8

  4. Pharmacokinetics parameters：T1/2、CL/F、Vz/F、Cmax,ss、Cmin,ss、Cav,ss、Tmax,ss、AUCtau,ss for Ginkgolides Meglumine Injection.

    Measured: Day 19 and Day22

  5. Pharmacokinetics parameters: Racc for Ginkgolides Meglumine Injection.

    Measured: Day 19

Secondary outcomes (1)

  1. Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, electrocardiograph monitoring and clinical laboratory tests.

    Adverse event reports will be assessed at Day1, Day 8-22, Day 23. Vital sign measurements will be assessed at Screening stage, Day 0, Day 1, Day 8-22, Day 23. Electrocardiogram monitoring will be assessed at Day 1, Day 8-22. Clinical laboratory tests will be assessed at Screening stage and Day 23. Electrocardiogram will be assessed at Screening stage, Day 0, Day 8-22 and Day 23

    Measured: Day 0, Day 1, Day 8-22 and Day 23

Timeline

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

  1. First posted9 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2014

Resources

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02233972
Sponsor's protocol ID
Z-YXPU-ZS-IV5
Status last verified
Aug 2014
First submitted
4 Sep 2014
Last updated
20 Oct 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Midazolam and Ginkgolides Meglumine Injection in people with Pharmacokinetics, run by Jiangsu Kanion Pharmaceutical Co., Ltd 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 6 inclusion and 13 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 20 Oct 2014. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Pharmacokinetics parameters：Cmax、Tmax、AUC0-24h、T1/2、CL/F、Vz/F for Midazolam. (time frame: Day 1 and Day 22). The study lists 5 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 NCT02233972.

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 20 Oct 2014.

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