Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 59 of 450 for:    QUETIAPINE

Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01871987
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
A study to evaluate the effect of food on the plasma concentration changes of quetiapine after oral administration of FK949E (extended release formulation of quetiapine) in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Plasma Concentration Change of Quetiapine Drug: FK949E Phase 1

Detailed Description:
This is a 3-way cross-over study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetic Study of FK949E -A Pharmacokinetic Study in Healthy Male Volunteers to Investigate the Effect of Food on the Pharmacokinetics of FK949E
Study Start Date : June 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fasted group
receiving FK949E in fasted condition
Drug: FK949E
oral
Other Name: extended release formulation of quetiapine

Experimental: low fat group
receiving FK949E after low fat meal
Drug: FK949E
oral
Other Name: extended release formulation of quetiapine

Experimental: high fat group
receiving FK949E after high fat meal
Drug: FK949E
oral
Other Name: extended release formulation of quetiapine




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) of unchanged quetiapine [ Time Frame: For 48 hours after dosing ]
  2. AUC (area under the curve) of unchanged quetiapine [ Time Frame: For 48 hours after dosing ]

Secondary Outcome Measures :
  1. tmax of plasma concentration of unchanged quetiapine [ Time Frame: For 48 hours after dosing ]
  2. t1/2 of plasma concentration of unchanged quetiapine [ Time Frame: For 48 hours after dosing ]
  3. Safety assessed by the incidence of adverse events, clinical lab tests, vital signs, 12-lead ECGs and physical exam [ Time Frame: Up to 48 hours after each administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight : ≥50.0 kg, <85.0 kg
  • Body Mass Index : ≥17.6, <26.4
  • Healthy, as judged by the investigator/subinvestigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission in Period 1 to immediately before study medication

Exclusion Criteria:

  • Subjects with the following history.

    1. Hepatic disease (e.g. viral hepatitis, drug-induced liver injury).
    2. Heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring

      treatment).

    3. Respiratory disease (e.g. serious bronchial asthma, chronic bronchitis)
    4. Gastrointestinal disease (e.g. serious peptic ulcer, gastroesophageal reflux esophagitis;

      diseases requiring several selections except for appendicitis)

    5. Renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis).
    6. Cerebrovascular disorder (e.g. cerebral infarction).
    7. Malignant tumor.
    8. Drug allergies. Allergic disorders (except for hay fever)
    9. Any use of drugs abuse. Alcohol abuse
  • Any concurrent illness (except for caries)
  • A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG at screening or upon admission in Period 1 (day preceding the day of study medication).
  • Any deviation of the following criteria for clinical laboratory tests at screening or upon admission in Period 1 (day preceding the day of study medication). The normal reference ranges specified at the study site will be used as the normal reference ranges in the present study.

    1. Hematology:

      • A deviation of ±20% from the upper or lower limit of the normal range
    2. Blood biochemistry:

      • A deviation from the normal range for AST, ALT, creatinine (Cre), or serum electrolytes.
      • A deviation of ±20% from the upper or lower limit of the normal range for other items than the above.
      • However, the lower limit of the normal range will not be established for items for which a deviation from the lower limit is not considered clinically significant[AST, ALT, total bilirubin (T-Bil), ALP, γ-GTP, LDH, CK, Cre, uric acid (UA)and total cholesterol (T-Cho)].
    3. Urinalysis:

      • U-Glu, U-Pro ≥+1
      • U-Uro ≥+2
    4. Urinary drug test: A positive result for phencyclidine, benzodiazepine, cocaine, amphetamines, cannabis, opiates, barbiturates or tricyclic antidepressants
    5. Immunological test: A positive result for HBs antigen, HCV antibody, syphilis, or HIV antigen/antibody
  • Received medication within 14 days before hospital admission in Period 1 or is scheduled to receive medication
  • Received any investigational drugs in other clinical or post-marketing studies within 120 days before the screening assessment
  • Previous treatment with FK949E
  • Donated more than 400 mL of whole blood within 90 days, more than 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
  • Excessive smoking or drinking habit (measure of "excessive": alcohol: 45 g/day [a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol], smoking: 20 cigarettes/day).
  • Other subjects concerned ineligible by the investigator/subinvestigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871987


Locations
Layout table for location information
Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Layout table for investigator information
Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01871987     History of Changes
Other Study ID Numbers: 6949-CL-0003
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Astellas Pharma Inc:
FK949E
Quetiapine
Antipsychotic
Additional relevant MeSH terms:
Layout table for MeSH terms
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs