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NCT04265456 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers
A Phase 1 study of Postoperative Pain, sponsored by Nevakar.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT04265456 is a Phase 1 study of Postoperative Pain that has completed, run by Nevakar. The registered enrollment target is 63 participants, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04265456, a Phase 1 study of Postoperative Pain, has completed, sponsored by Nevakar.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
Conditions Studied
Interventions
- DRUG Pregabalin 100mg
- DRUG Acetaminophen 1300mg
Study Locations (1)
California
- Lotus Clinical Resarch,LLC - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2020-01-14 |
| Est. Completion | 2020-07-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04265456
The ClinicalTrials.gov registry entry for NCT04265456 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 63 other Postoperative Pain trials with a reported enrollment target (73% lower). The listed sponsor is Nevakar, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Pregabalin 100mg is the first listed.
NCT04265456 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04265456 about?
NCT04265456 is a clinical study titled "A Phase 1 Study to Evaluate Pregabalin and Acetaminophen in Healthy Volunteers". This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to determine a maximum tolerated dose of IV PGB and to evaluate the safety, tolerability, and PK of an admixture of IV PGB and a fixed dose of 1300 mg IV APAP in healthy adult volunteers.
What is the current status of trial NCT04265456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2020-01-14. Estimated completion is 2020-07-22.
What conditions does trial NCT04265456 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT04265456?
The interventions under investigation include: Pregabalin 100mg (DRUG), Acetaminophen 1300mg (DRUG).
Who is sponsoring clinical trial NCT04265456?
This trial is sponsored by Nevakar, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04265456 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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