Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

NCT05181007 | Completed Phase 1 FDA Drug

• 1 other identifier: HSK3486-111
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

study the effect of mefanamic acid or valproate on ciprofol

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (4)

• effect of mefanamic acid on the Cmax of ciprofol

  Peak Plasma Concentration (Cmax)

  0-24hour post ciprofol dosing

• effect of mefanamic acid on the AUC of ciprofol

  Area under the plasma concentration versus time curve (AUC)

  0-24hour post ciprofol dosing

• effect of valproate on the Cmax of ciprofol

  Peak Plasma Concentration (Cmax)

  0-24hour post ciprofol dosing

• effect of valproate on the AUC of ciprofol

  Area under the plasma concentration versus time curve (AUC)

  0-24hour post ciprofol dosing

Secondary Outcomes (3)

• Safety when ciprofol is co-administered with mefanamic acid or valproate

  0-24hour post ciprofol dosing

• effect of mefanamic acid or valproate on the MOAA/S of ciprofol

  0-24hour post ciprofol dosing

• effect of mefanamic acid or valproate on the BIS of ciprofol

  0-24hour post ciprofol dosing

Study Arms (2)

MFA

ACTIVE COMPARATOR

mefanamic acid

Drug: Mefanamic Acid

VPA

ACTIVE COMPARATOR

valproate

Drug: Valproate

Interventions

Mefanamic Acid DRUG

mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5

MFA

Valproate DRUG

valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8

VPA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The second affiliated hospital Zhejiang University School of Medicine

Hanzhou, China

Location

MeSH Terms

Interventions

Mefenamic Acid; Valproic Acid

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pentanoic Acids; Valerates; Acids, Acyclic; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 6, 2022
• Study Start: December 17, 2021
• Primary Completion: March 23, 2022
• Study Completion: June 1, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

CN (1)