Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

• Sponsor: Haisco Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05181007
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

study the effect of mefanamic acid or valproate on ciprofol

Condition or Disease	Intervention/Treatment	Phase
Drug Drug Interaction	Drug: Mefanamic Acid; Drug: Valproate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers
• Actual Study Start Date: Dec 17, 2021
• Actual Primary Completion Date: Mar 23, 2022
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: MFA mefanamic acid	Drug: Mefanamic Acid; mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5
Active Comparator: VPA valproate	Drug: Valproate; valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8

Outcome Measures

Primary Outcome Measures

1. effect of mefanamic acid on the Cmax of ciprofol [0-24hour post ciprofol dosing]

   Peak Plasma Concentration (Cmax)

2. effect of mefanamic acid on the AUC of ciprofol [0-24hour post ciprofol dosing]

   Area under the plasma concentration versus time curve (AUC)

3. effect of valproate on the Cmax of ciprofol [0-24hour post ciprofol dosing]

   Peak Plasma Concentration (Cmax)

4. effect of valproate on the AUC of ciprofol [0-24hour post ciprofol dosing]

   Area under the plasma concentration versus time curve (AUC)

Secondary Outcome Measures

1. Safety when ciprofol is co-administered with mefanamic acid or valproate [0-24hour post ciprofol dosing]

   Adverse event

2. effect of mefanamic acid or valproate on the MOAA/S of ciprofol [0-24hour post ciprofol dosing]

   MOAA/S

3. effect of mefanamic acid or valproate on the BIS of ciprofol [0-24hour post ciprofol dosing]

   BIS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital Zhejiang University School of Medicine	Hanzhou		China

Sponsors and Collaborators

• Haisco Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Haisco Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05181007
• Other Study ID Numbers: HSK3486-111
• First Posted: Jan 6, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Valproic Acid

Study Results

No Results Posted as of Jul 14, 2022