Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000857
First received: October 22, 2009
Last updated: April 5, 2012
Last verified: February 2011
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Purpose
The primary purpose of this study is to compare the steady-state pharmacokinetic profile of paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder Healthy Volunteer |
Drug: Paroxetine CR and Paroxetine IR |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Steady-state, Two-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Repeated Daily Dosing of the Controlled-release Paroxetine Tablet (25 mg) With That of the Standard Immediate-release Paroxetine Tablet (20 mg) in Healthy Japanese Male Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Depression
Drug Information available for:
Paroxetine
Paroxetine hydrochloride
Paroxetine hydrochloride hemihydrate
Paroxetine Mesylate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Pharmacokinetic parameters of plasma paroxetine after 14-days repeat dosing of paroxetine CR at 25mg/day or paroxetine IR at 20mg/day [ Time Frame: up to 96 hours after dosing on Day 14 of each treatment period of paroxetine CR or paroxetine IR ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and tolerability in healthy Japanese male volunteers during and after the repeat dosing period of paroxetine CR or paroxetine IR [ Time Frame: During the 14-days repeat dosing period and up to 96 hours after the last dose of paroxetine CR or paroxetine IR ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | November 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Open label treatment with 2-period crossover design
Group 1: Paroxetine CR 25 mg/day for 14 days / Paroxetine IR 20 mg/day for 14 days. Group 2: Paroxetine IR 20 mg/day for 14 days / Paroxetine CR 25 mg/day for 14 days., PK results will be compared between the Paroxetine CR treatment period and the Paroxetine IR treatment period. |
Drug: Paroxetine CR and Paroxetine IR
Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers
|
Detailed Description:
This study is an open, randomized, repeat dose, two-period crossover design in Japanese healthy male volunteers. This clinical trial is designed primarily to compare the steady-state pharmacokinetic profile of paroxetine CR at the dosage of 25mg /day (25mg once daily for 14 days) using the proposed final market tablet of CR 25mg in Japan with that of paroxetine IR at the dosage of 20mg/day (20mg once daily for 14 days) using the currently marketed IR 20mg tablet in Japan, by the crossover oral repeat dosing manner.
Eligibility| Ages Eligible for Study: | 20 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy Japanese adult males between 20 and 64 years of age inclusive
- BMI 18.50 or higher and < 25.00 kg/m2, and bodyweight 50 kg or higher
- Non-smokers
- AST, ALT, ALP, gamma-GTP and total-bilirubin are below the upper limit of normal range
- QTc(B) interval <450 msec
- Able to attend all visits and complete the study
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion Criteria:
- Any clinically relevant abnormality on the screening physical examination, vital signs, 12-lead ECG and/or clinical laboratory tests
- Medical history that is not considered as eligible for inclusion in this study by the investigator
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones)
- History of psychiatric disorder or suicide attempts or behaviours
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
- History of sensitivity to any of the paroxetine formulations, or components thereof
- Positive for urine drug screening
- Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device
- Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication
- History of drug or other allergy, or idiosyncrasy, excluding a pollen allergy without current symptoms
- History of drug abuse, or current conditions of drug abuse or alcoholism
- History of regular alcohol consumption exceeding, on average, 14 drinks/week (1 drink = 150 mL of wine or 350 mL of beer or 45 mL of 80 proof distilled spirits) within 6 months of screening
- Use of prescription or no-prescription drugs, including vitamins, crude drug, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication
- Unwillingness or inability to follow the procedures outlined in the protocol
- Consumption of grapefruit or grapefruit-containing products from 7 days prior to the first dose of study medication
- Positive for syphilis, HIV antibody and antigen, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody
- Donation of blood in excess of 400mL within the previous 4 months or 200mL within the previous 1 month to the first dose of study medication
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01000857 History of Changes |
| Other Study ID Numbers: | 112812 |
| Study First Received: | October 22, 2009 |
| Last Updated: | April 5, 2012 |
| Health Authority: | Japan: Pharmaceutical and Medical Device Agency |
Keywords provided by GlaxoSmithKline:
|
safety Japanese healthy male volunteers repeat dose crossover controlled-release tablet |
immediate-release tablet paroxetine pharmacokinetics steady-state tolerance |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Mood Disorders Mental Disorders Behavioral Symptoms Paroxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013