drugset / Trial / NCT05563961
A Partial Randomized, Single-blind or Open-label, Dose-escalation With Multiple-dose Design Study to Evaluate the Pharmacokinetics of Acetaminophen and Its Toxic Metabolites With Panadol® and SafeTynadol® in Healthy Volunteers
Non-randomizedSequentialSingle-blindPrevention
Summary
To investigate and compare the possible response of Panadol® and SafeTynadol® formulations in healthy volunteers and the safety in SafeTynadol® dose-limiting hepatotoxicity.
Timeline
- Start
- 2022-10-28
- Primary completion
- 2024-06
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 1000 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 1500 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 2000 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 2500 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 3000 mg | Oral |