---
title: Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers
nct_id: NCT02180477
overall_status: COMPLETED
phase: PHASE1
sponsor: Boehringer Ingelheim
study_type: INTERVENTIONAL
primary_condition: Healthy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02180477.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02180477"
ct_last_update_post_date: 2014-07-08
last_seen_at: "2026-05-12T07:14:10.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation in Healthy Male Volunteers

**Official Title:** Preliminary Bioequivalence Study of UHAC 62 XX Tablets Compared With a Capsule Formulation

**NCT ID:** [NCT02180477](https://clinicaltrials.gov/study/NCT02180477)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** Boehringer Ingelheim
- **Conditions:** Healthy
- **Start Date:** 2001-11
- **CT.gov Last Update:** 2014-07-08

## Brief Summary

Study to investigate the relative bioavailability of UHAC 62 XX capsule and two different tablet formulations (TF1 and TF2), and to obtain data for rational design of a subsequent pivotal bioequivalence (BE) study between capsule and tablet formulations.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 35 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Age \>= 20 and \<= 35 years
* Weight: BMI \>= 18.5 and \< 25 (Weight (kg) / Height (m²)
* Subjects who are judged by the investigator to be appropriate as the subjects of the study based on results of screening test
* Subjects who volunteer to participate and are able to fully understand and agree with this study by written informed consent

Exclusion Criteria:

* History of gastrointestinal ulcer or surgery of gastrointestinal tract (except appendectomy)
* History of hypersensitivity to meloxicam and/or salicylate (aspirin) and/or Non-steroidal anti-inflammatory drugs (NSAIDs)
* History of aspirin induced asthma (bronchial asthma induced by NSAIDs)
* History of alcohol or drug abuse
* Participation to another trial with an investigational drug within 4 months prior to the administration
* Whole blood donation more than 400 ml within 3 months prior to the administration
* Whole blood donation more than 100 ml within 1 month prior to the administration
* Donation of constituent of blood of more than 400 ml within 1 month prior to the administration
* Any medication within 10 days prior to the administration
* Excessive physical activities within 7 days prior to the administration
* Alcohol drinking within 3 days prior to the administration
* History of orthostatic hypotension, fainting spells or blackouts
* Other than above, those who are judged by the investigator to be inappropriate as the subjects of the study
```

## Arms

- **UHAC 62 XX TF1 tablet** (EXPERIMENTAL)
- **UHAC 62 XX TF2 tablet** (EXPERIMENTAL)
- **UHAC 62 XX capsule** (ACTIVE_COMPARATOR)

## Interventions

- **UHAC 62 XX - TF1 tablet** (DRUG)
- **UHAC 62 XX - TF2 tablet** (DRUG)
- **UHAC 62 XX - capsules** (DRUG)

## Primary Outcomes

- **Cmax (Maximum observed concentration in plasma)** _(time frame: up to 72 hours after administration)_
- **AUC 0-72hr (Area under the concentration-time curve in plasma from zero time to 72 hours)** _(time frame: up to 72 hours after administration)_

## Secondary Outcomes

- **tmax (Time to reach maximum concentration)** _(time frame: up to 72 hours after administration)_
- **t1/2 (Terminal half-life in plasma)** _(time frame: up to 72 hours after administration)_
- **AUC 0-infinity (Area under the concentration-time curve in plasma from zero time to infinity)** _(time frame: up to 72 hours after administration)_
- **MRT 0-t (Mean residence time in the body from zero time to the time of the last quantifiable drug concentration)** _(time frame: up to 72 hours after administration)_
- **Number of patients with adverse events** _(time frame: up to 14 days after last administration)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02180477.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02180477*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*