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A Study Evaluating the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection

CompletedPhase 1NCT07710560
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

To evaluate the pharmacokinetic interaction of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the safety and tolerability of KL0011034 injection in combination with alfentanil hydrochloride injection.To evaluate the effect of alfentanil hydrochloride injection on the pharmacodynamics of KL0011034 injection.

Study details

Official title
A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period Crossover Study to Evaluate the Drug-Drug Interaction Between KL0011034 Injection and Alfentanil Hydrochloride Injection
Conditions
Interventions
  • Drug: KL0011034 injection
  • Drug: Alfentanil Hydrochloride Injection
Sponsor
Hunan Kelun Pharmaceutical Co., Ltd.
Start date
2026-07-15
Primary completion
2026-08-12
Sex
All
Age range
from 18 Years to 55 Years
Results posted
No results posted in this snapshot
Countries
China
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. patients with moderate-to-severe non-cancerous chronic pain (Age: 18\~55 years, NRS score≥4); 2. Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0; 3. There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, chest x-ray, abdominal B-ultrasound, laboratory tests; Exclusion Criteria: 1. Allergy or Drug hypersensitivity; 2. Clinically significant Medical History; 3. History of anesthesia accident, history of serious adverse reactions of anesthesia, or family history of anesthesia accidents, or contraindications to general anesthesia; 4. Dyspnoea or suspected difficult airway, or predicting difficult endotracheal intubation; 5. History of bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome; 6. History of adrenal insufficiency or adrenal tumor or hereditary heme biosynthesis disorder or hereditary acute porphyria; 7. History of any surgery within 3 months; 8. History of any Medication within 14 days; 9. History of any inducers or inhibitors of CYP3A4 or CYP2C19 enzymes within 30 days; 10. History of any clinical study within 3 months; 11. History of any vaccine within 1 month; 12. History of any drug abuse; 13. Needle sickness, Hematosickness; 14. Massive blood loss (\> 400 mL) in the past 3 months; 15. Female volunteers are pregnant or lactating; 16. History of unprotected sex within 2 weeks; 17. Heavy smoker ( more than 5 cigarettes/day) within 3 months; 18. History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months; 19. Heavy caffeine intake; 20. History of grapefruit, xanthine-rich foods intake within 48 hours; 21. Positive alcohol test; 22. Positive nicotine test; 23. Positive drugs of abuse test result.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07710560