Drug-drug Interaction Between Ciprofol and Mefanamic Acid or Valproate

Drug Drug Interaction Clinical Trial

Official title:

An Open-label, Two-stage Study Evaluating Drug-drug Interaction Between Ciprofol Injectable Emulsion and Mefanamic Acid or Valproate in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181007
• Other study ID #: HSK3486-111
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2022
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

study the effect of mefanamic acid or valproate on ciprofol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: June 1, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• Mefanamic Acid
mefanamic acid once every 6 hours on Day 4 and Day 5, Ciprofol on Day 1 and Day 5
• Valproate
valproate once daily on Day 4 to Day 8, Ciprofol on Day 1 and Day 8

Locations

Country	Name	City	State
China	The second affiliated hospital Zhejiang University School of Medicine	Hanzhou

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of mefanamic acid on the Cmax of ciprofol	Peak Plasma Concentration (Cmax)	0-24hour post ciprofol dosing
Primary	effect of mefanamic acid on the AUC of ciprofol	Area under the plasma concentration versus time curve (AUC)	0-24hour post ciprofol dosing
Primary	effect of valproate on the Cmax of ciprofol	Peak Plasma Concentration (Cmax)	0-24hour post ciprofol dosing
Primary	effect of valproate on the AUC of ciprofol	Area under the plasma concentration versus time curve (AUC)	0-24hour post ciprofol dosing
Secondary	Safety when ciprofol is co-administered with mefanamic acid or valproate	Adverse event	0-24hour post ciprofol dosing
Secondary	effect of mefanamic acid or valproate on the MOAA/S of ciprofol	MOAA/S	0-24hour post ciprofol dosing
Secondary	effect of mefanamic acid or valproate on the BIS of ciprofol	BIS	0-24hour post ciprofol dosing