---
title: Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)
nct_id: NCT06595121
overall_status: COMPLETED
phase: PHASE1
sponsor: Unither Pharmaceuticals, France
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06595121.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06595121"
ct_last_update_post_date: 2024-11-08
last_seen_at: "2026-05-12T06:39:18.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)

**Official Title:** Comparative Bioavailability Study of Budesonide After Inhalation of Budesonide 1 Mg / 2 Ml Nebuliser Suspension (Test Product 08P1707F0): Administration Without and with Activated Charcoal and Inhalation of Pulmicort® 1.0 Mg / 2 Ml Suspension (Reference Product) in Healthy Subjects

**NCT ID:** [NCT06595121](https://clinicaltrials.gov/study/NCT06595121)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Unither Pharmaceuticals, France
- **Collaborators:** Analytical Clinical Concepts (ACC GmbH)
- **Conditions:** Healthy
- **Start Date:** 2024-08-13
- **Completion Date:** 2024-09-16
- **CT.gov Last Update:** 2024-11-08

## Brief Summary

This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy, Caucasian, male and female (16 male, 8 female) subjects 18 - 55 years of age
* Body mass index within the range of ≥ 18.5 and ≤ 30.0 kg/m2
* Female subjects of childbearing potential1) agree to undergo pregnancy tests and to use at least an acceptable effective birth control method during the study and until 90 days after study end
* Negative Covid-19 test result
* Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study)
* Normal Electrocardiograms (ECG) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
* Normal vital signs (normal blood pressure and heart rate measured under stabilised conditions at screening visit after at least 5 minutes of rest in sitting position: systolic blood pressure 100 - 140 mmHg, diastolic blood pressure 60 - 90 mmHg and heart rate 50 - 100 beats per minute; normal body temperature (Forehead, 35.5 °C - 37.0 °C)) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study (...)

Exclusion Criteria:

* History of hypersensitivity to the study drug or any related drugs or to any of the excipients
* History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma
* Clinically significant abnormal laboratory values
* Clinically significant ECG findings
* Clinically significant vital signs (...)
```

## Arms

- **IMP 08P1707F0 without charcoal** (EXPERIMENTAL) — Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal
- **IMP 08P1707F0 with charcoal** (EXPERIMENTAL) — Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal
- **Pulmicort 1.0mg/2mL Suspension** (ACTIVE_COMPARATOR) — Pulmicort 1.0mg/2mL Suspension (First administration)
- **Pulmicort 1.0mg/ML suspension (second administration)** (ACTIVE_COMPARATOR) — Pulmicort 1.0mg/ML suspension (second administration)

## Interventions

- **budesonide** (DRUG) — Budesonide 1 mg/2mL nebuliser suspension
- **budesonide** (DRUG) — Pulmicort(r) 1 mg/2mL nebuliser suspension
- **Activated Charcoal** (OTHER) — suspension of 10g activated charcoal slurried in 70mL of water

## Primary Outcomes

- **Cmax of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_ — The maximum concentration in plasma among observed concentrations at pre-specified time points
- **AUC 0-t of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_ — The area under the curve of plasma concentration versus time curve from time O to the last measured concentration

## Secondary Outcomes

- **AUC 0-∞ of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_
- **AUC t-∞ of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_
- **AUC O-30 min of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42 and 0.50 hours)_
- **t max of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_
- **t 1/2 of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_
- **AUC O-15 min of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17 and 0.25 hours)_
- **λz of budesonide for the differents arms** _(time frame: predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours)_
- **Incidence of treatment-related adverse events** _(time frame: up to 24 hours)_

## Locations (1)

- Farmagen IKU Merkezi, Gaziantep, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — 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)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.farmagen iku merkezi|gaziantep||turkey (türkiye)` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06595121.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06595121*  
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