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Trial record 5 of 89 for:    DESVENLAFAXINE

Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®

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: NCT03357796
Recruitment Status : Completed
First Posted : November 30, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Luye Pharma Group Ltd.

Tracking Information
First Submitted Date  ICMJE November 21, 2017
First Posted Date  ICMJE November 30, 2017
Last Update Posted Date January 4, 2018
Actual Study Start Date  ICMJE November 27, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
  • Area under the concentration-time curve (AUC) Assessment [ Time Frame: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2. ]
    Area under the concentration-time curve (AUC) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
  • Maximum concentration (Cmax) Assessment [ Time Frame: PK Samples drawn at 0, 1,2,3,4, 6,8,10,12,24,32,48 and 72 hours after dosing in both Period 1 and Period 2. ]
    Maximum concentration (Cmax) for the Pharmacokinetics (PK) of O-desmethyl-venlafaxine (ODV) from LY03005 and ODV from Pristiq will be determined.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03357796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2017)
Adverse Events Assessment [ Time Frame: up to 35 days ]
Collection of adverse events throughout the study as a measure of safety and tolerability.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®
Official Title  ICMJE A Randomized, Open-label, Cross-over, 2-period Study to Assess the Relative Bioavailability Between 80 mg LY03005 Versus 50 mg Desvenlafaxine Comparator (Pristiq®) Under Fasting Condition After Single Dose Administration in Healthy Subjects
Brief Summary The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in healthy subjects between 18 and 50 years of age.
Detailed Description Twenty (20) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: LY03005
    80 mg, oral tablets, single dose
  • Drug: Pristiq
    50 mg, oral tablets, single dose
    Other Name: Desvenlafaxine
Study Arms  ICMJE
  • Experimental: Group A: LY03005 cross-over to Pristiq®
    Subjects in Group A will receive an 80 mg oral dose of LY03005 and the subjects will stay in the CRU for 4 days (Period 1). After a washout period of up to 4 days, the subjects will be switched and will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) comparator followed by a 4-day stay in the CRU (Period 2).
    Interventions:
    • Drug: LY03005
    • Drug: Pristiq
  • Experimental: Group B: Pristiq® cross-over to LY03005
    Subjects in Group B will receive a 50 mg oral dose of desvenlafaxine (Pristiq®) comparator and the subjects will stay in the CRU for 4 days (Period 1). After a washout period of up to 4 days, the subjects will be switched and will receive an 80 mg oral dose of LY03005 followed by a 4-day stay in the CRU (Period 2).
    Interventions:
    • Drug: LY03005
    • Drug: Pristiq
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 22, 2017
Actual Primary Completion Date December 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Capable of giving informed consent and complying with study procedures;
  2. Male and female subjects between the ages of 18 and 50 years;
  3. Considered healthy as assessed by the principal investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG, and vital signs;
  4. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before Screening based on subject report;
  5. Body mass index (BMI) of 19 to 28 kg/m2 inclusive and body weight not less than 50 kg;
  6. Willing and able to adhere to study procedures and to be confined at the clinical research center.
  7. All female subjects no matter of age must have a negative serum pregnancy test result at Screening. In addition, female subjects must meet one of the following 3 conditions: (i) postmenopausal for at least 2 years, (ii) surgically sterile based on subject report, or (iii) if child-bearing potential, practicing or agree to practice an effective method of birth control by using an acceptable method of contraception. Acceptable methods of birth control include intrauterine device (IUD), or double-barrier method (e.g., condom, diaphragm or cervical cap with spermicidal foam, cream, gel or suppository). Acceptable methods of birth control must be used for at least 14 days prior to the use of study drug during the study and within 1 month after the end of the study.

Exclusion Criteria:

  1. Clinically significant past medical history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, ophthalmological, or drug hypersensitivity or any condition that in the judgement of the investigator will affect the study results or the subject's safety;
  2. History of suicide attempt in the past 12 months and/or seen by the investigators as having a significant history of risk of suicide or homicide;
  3. History or presence of malignancy other than adequately treated and cured basal cell skin cancer;
  4. Clinically relevant illness within 1 month prior to the Screening Visit or at Screening Visit that may interfere with the conduct of this study;
  5. Subjects with a mean systolic blood pressure >140 mmHg or a mean diastolic blood pressure of >90 mmHg at Screening after 3 measurements (after 5 minutes of rest in a sitting position);
  6. Positive blood Screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
  7. A history of seizure. However, a history of febrile seizure is allowed;
  8. A hospital admission or major surgery within 30 days prior to Screening;
  9. Participation in any other investigational drug trial within 30 days prior to Screening;
  10. A history of prescription drug abuse or illicit drug use within 6 months prior to Screening;
  11. A history of alcohol abuse according to medical history within 6 months prior to Screening;
  12. A positive screen for alcohol and drugs of abuse;
  13. Subjects with hypersensitivity to ODV or medicines containing ODV or its precursor venlafaxine;
  14. Subjects who have participated in a previous clinical study of either LY03005 or ODV or medicines containing ODV or its precursor, venlafaxine within 30 days prior to Screening;
  15. Unwillingness or inability to comply with food and beverage restrictions during study participation;
  16. Donation of blood of more than 1 unit (approximate 450 mL) or blood products or acute loss of blood during the 90 days prior to Screening;
  17. Use of prescription or over-the-counter (OTC) medications, and herbals (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at <3g/day is permitted until 24 hours prior to dosing).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03357796
Other Study ID Numbers  ICMJE LY03005/CT-USA-104
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Luye Pharma Group Ltd.
Study Sponsor  ICMJE Luye Pharma Group Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Amy Sun, MD, PhD, MBA Luye Pharma Group Ltd.
PRS Account Luye Pharma Group Ltd.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP