# A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition

> **NCT01778075** · PHASE1 · COMPLETED · sponsor: **Janssen Korea, Ltd., Korea** · enrollment: 56 (actual)

## Conditions studied

- Healthy

## Interventions

- **DRUG:** Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)
- **DRUG:** Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)

## Key facts

- **NCT ID:** NCT01778075
- **Lead sponsor:** Janssen Korea, Ltd., Korea
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2012-12
- **Primary completion:** 2013-02
- **Final completion:** 2013-02
- **Target enrollment:** 56 (ACTUAL)
- **Last updated:** 2014-02-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01778075

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01778075, "A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01778075. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*