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Trial record 5 of 89 for:    DESVENLAFAXINE

Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®

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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.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: LY03005 Drug: Pristiq Phase 1

Detailed Description:
Twenty (20) eligible subjects will be enrolled and assigned to either Group A or Group B at a 1:1 ratio.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : December 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
Drug: LY03005
80 mg, oral tablets, single dose

Drug: Pristiq
50 mg, oral tablets, single dose
Other Name: Desvenlafaxine

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).
Drug: LY03005
80 mg, oral tablets, single dose

Drug: Pristiq
50 mg, oral tablets, single dose
Other Name: Desvenlafaxine




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Adverse Events Assessment [ Time Frame: up to 35 days ]
    Collection of adverse events throughout the study as a measure of safety and tolerability.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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): NCT03357796


Locations
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United States, New Jersey
Clinilabs, Inc.
Eatontown, New Jersey, United States, 07724
Sponsors and Collaborators
Luye Pharma Group Ltd.
Investigators
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Study Chair: Amy Sun, MD, PhD, MBA Luye Pharma Group Ltd.

Additional Information:
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Responsible Party: Luye Pharma Group Ltd.
ClinicalTrials.gov Identifier: NCT03357796     History of Changes
Other Study ID Numbers: LY03005/CT-USA-104
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luye Pharma Group Ltd.:
Desvenlafaxine Succinate
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs
Additional relevant MeSH terms:
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Desvenlafaxine Succinate
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Neurotransmitter Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents
Psychotropic Drugs