Drug Drug InteractionPhase 1NCT05181007
Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate
A Phase 1 study testing Mefanamic Acid and Valproate in people with Drug Drug Interaction, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
study the effect of mefanamic acid or valproate on ciprofol Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Mefanamic Acid and Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2021to 1 Jun 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal results of physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), and 12-lead ECG, or considered by the investigator to be clinically insignificant abnormalities; no significant potential difficult airway (modified Mallampati score Class I-II);
- No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Understand procedures and methods of this trial, willing to sign the informed consent form and comply strictly with the clinical trial protocol to complete this study.
Who cannot join
- Known allergies to excipients of ciprofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide), mefanamic acid, or valproate, or having contraindications to ciprofol/mefanamic acid/valproate; a history of drug allergies (including anesthetics), allergies, or prone to allergies;
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital Zhejiang University School of Medicine
Hanzhou
About this study
Official title: An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers
study the effect of mefanamic acid or valproate on ciprofol
- Conditions
- Drug Drug Interaction
- Being tested
- Mefanamic Acid, Valproate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefanamic AcidDrug
mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5
ValproateDrug
valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8
| Study group | Role | What they receive |
|---|---|---|
| MFA | Active comparator | mefanamic acid Receives: Drug: Mefanamic Acid |
| VPA | Active comparator | valproate Receives: Drug: Valproate |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of mefanamic acid on the Cmax of ciprofol
Peak Plasma Concentration (Cmax)
Measured: 0-24hour post ciprofol dosing
effect of mefanamic acid on the AUC of ciprofol
Area under the plasma concentration versus time curve (AUC)
Measured: 0-24hour post ciprofol dosing
effect of valproate on the Cmax of ciprofol
Peak Plasma Concentration (Cmax)
Measured: 0-24hour post ciprofol dosing
effect of valproate on the AUC of ciprofol
Area under the plasma concentration versus time curve (AUC)
Measured: 0-24hour post ciprofol dosing
Secondary outcomes (3)
Safety when ciprofol is co-administered with mefanamic acid or valproate
Adverse event
Measured: 0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the MOAA/S of ciprofol
MOAA/S
Measured: 0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the BIS of ciprofol
BIS
Measured: 0-24hour post ciprofol dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start17 Dec 2021
- Primary completion23 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181007
- Sponsor's protocol ID
- HSK3486-111
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05181007
- Acronym / sponsor ID
- HSK3486-111
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Jan 2022 (actual)
- 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.
study the effect of mefanamic acid or valproate on ciprofol
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MFA | Active comparator | Drug: Mefanamic Acidmefanamic acid |
| VPA | Active comparator | Drug: Valproatevalproate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Normal results of physical examination, laboratory tests (blood routine, blood biochemistry, and urine routine), and 12-lead ECG, or considered by the investigator to be clinically insignificant abnormalities; no significant potential difficult airway (modified Mallampati score Class I-II);
- No previous history of primary diseases in major organs, such as liver, kidneys, digestive tract, blood, and metabolic diseases; no history of malignant hyperthermia and other hereditary disorders; no history of mental/neurological disorders; no history of epilepsy; no contraindications for deep sedation/general anesthesia; no clinically significant history of anesthesia accidents;
- Understand procedures and methods of this trial, willing to sign the informed consent form and comply strictly with the clinical trial protocol to complete this study.
Key exclusion criteria (1 listed)
- Known allergies to excipients of ciprofol injectable emulsion (soybean oil, glycerin, triglyceride, egg lecithin, sodium oleate, and sodium hydroxide), mefanamic acid, or valproate, or having contraindications to ciprofol/mefanamic acid/valproate; a history of drug allergies (including anesthetics), allergies, or prone to allergies;
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 |
|---|---|---|
| Mefanamic Acidmefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5 | Drug | MFA |
| Valproatevalproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8 | Drug | VPA |
Primary outcome
effect of mefanamic acid on the Cmax of ciprofol
Time frame: 0-24hour post ciprofol dosing
Peak Plasma Concentration (Cmax)
effect of mefanamic acid on the AUC of ciprofol
Time frame: 0-24hour post ciprofol dosing
Area under the plasma concentration versus time curve (AUC)
effect of valproate on the Cmax of ciprofol
Time frame: 0-24hour post ciprofol dosing
Peak Plasma Concentration (Cmax)
effect of valproate on the AUC of ciprofol
Time frame: 0-24hour post ciprofol dosing
Area under the plasma concentration versus time curve (AUC)
3 secondary outcomes
Safety when ciprofol is co-administered with mefanamic acid or valproate
Time frame: 0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the MOAA/S of ciprofol
Time frame: 0-24hour post ciprofol dosing
effect of mefanamic acid or valproate on the BIS of ciprofol
Time frame: 0-24hour post ciprofol dosing
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 14 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mefanamic Acid and Valproate in people with Drug Drug Interaction, run by Haisco Pharmaceutical Group 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 3 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 14 Jul 2022. 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?
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?
effect of mefanamic acid on the Cmax of ciprofol (time frame: 0-24hour post ciprofol dosing). 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?
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 14 Jul 2022.