Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®



Status:Completed
Conditions:Depression, Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 50
Updated:1/6/2018
Start Date:November 27, 2017
End Date:December 22, 2017

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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

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.

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

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).
We found this trial at
1
site
Eatontown, New Jersey 07724
Principal Investigator: Magdy Shenouda, MD
Phone: 212-994-4152
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mi
from
Eatontown, NJ
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