## Protocol Section
### Identification Module
**NCT ID:** NCT00924079

**Acronym:** NAL

**Brief Title:** The Development of Oral Nalbuphine Dosage Form

**Official Title:** Pharmacokinetic Study of Oral Nalbuphine in Normal Healthy Subjects

#### Organization Study ID Info
**ID:** NAL001
#### Organization
**Class:** OTHER
**Full Name:** Tri-Service General Hospital
#### Secondary ID Infos
**ID:** TSGHIRB096-02-010-I
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2009-06-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2009-06-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2009-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-09

**Status Verified Date:** 2009-06

#### Study First Post Date
**Date:** 2009-06-18
**Type:** ESTIMATED
**Study First Submit Date:** 2009-06-17
**Study First Submit QC Date:** 2009-06-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tri-Service General Hospital

#### Responsible Party

**Old Name Title:** Ho Shung-Tai/Professor of the department of anesthsiology

**Old Organization:** Department of anesthsiology of Tri-service General Hospitial

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to investigate possible responses to pharmacokinetic properties for nalbuphine oral formulations in healthy volunteers.

### Conditions Module

**Conditions:**

- Healthy

**Keywords:**

- Analysis of plasma concentration of nalbuphine

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: nalbuphine

**Label:** nalbuphine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- nalbuphine

**Description:** oral dosage form, 66 mg, single dose

**Name:** nalbuphine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Pharmacokinetic parameter eq Cmax, AUC, Cl, T1/2

**Time Frame:** 24 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Normal healthy adult subjects between 20-40 years of age.
* Body weight within 80-120% of ideal body weight. Ideal body weight = (height-80)0.7
* Acceptable medical history and physical examination including:

  * Normal chest X-ray and ECG results within six months prior to Period I dosing.
  * No particular clinical significance in general disease history within two months prior to Period I dosing.
* Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes:

  * AST (SGOT)
  * ALT (SGPT)
  * Gama-GT
  * alkaline phosphatase
  * total bilirubin
  * albumin
  * glucose
  * BUN
  * uric acid
  * creatinine
  * total cholesterol
  * triglyceride(TG)
* Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
* Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
* Signed the written informed consent to participate in this study.

Exclusion Criteria:

* Recent history of drug or alcohol addiction or abuse.
* A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
* History of allergic response(s) to nalbuphine or related drugs.
* History of clinically significant allergies including drug allergies or allergic bronchial asthma.
* Evidence of chronic or acute infectious diseases.
* Any clinically significant illness or surgery during the four weeks prior to Period I dosing (as determined by the clinical investigator).
* Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
* Receiving any investigational drug within one month prior to Period I dosing.
* Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
* Donating greater than 150 ml of blood within two months prior to Period I dosing or donating plasma (e.g., plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
* Consumption of caffeine, xanthine-containing products (i.e., coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol at least 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
* Any other medical reason as determined by the clinical investigator.
* Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test at Baseline.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Taipei

**Contacts:**

***Contact 1:***

- **Email:** painlab@ndmctsgh.edu.tw

- **Name:** Ho Shung-Tai, MD

- **Phone:** 886-2-87927125

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ho Shung-Tai, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Taiwan

**Facility:** Tri-Service General Hospitial

**Status:** RECRUITING

**Zip:** 11490

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M12217

- Name: Nalbuphine

- Relevance: HIGH

- As Found: Cabozantinib

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009266

- Term: Nalbuphine

### Misc Info Module

- Version Holder: 2024-05-24
