TCTR20240706012
Not yet recruiting
Phase 1
A randomized, open-labeled, multiple-dose, two-way crossover design with two-period, two-treatment, two-sequence steady-state bioequivalence study of Venlafaxine Hydrochloride Extended-Release Capsules 150 mg and Efexor XR 150 mg Capsules in healthy, adult, Thai volunteers under fed condition
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy subjects
- Sponsor
- Bio-innova Co., Ltd.
- Enrollment
- 44
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Willingness to provide written informed consent prior to participate in the study.
- •2\.Healthy Thai subjects are between 18 to 55 years of age.
- •3\.The Body Mass Index (BMI) ranges from 18\.5 to 30\.0 kg/m2\.
- •4\.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects safety after the completion of the study.
- •5\.Negative urine pregnancy test for women and no breast\-feeding.
- •6\.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician
Exclusion Criteria
- •1\.History or evidence of allergy or hypersensitivity to Venlafaxine or Desvenlafaxine succinate or any related drugs or any of the excipients of this product.
- •2\.Subject with B.P. is Systolic B.P \< 90, \>\=140 mm/Hg, Diastolic B.P \< 60, \>\=90 mm/Hg, pulse rate \> 100 beats per minute.
- •3\.Serum bilirubin greater than 1\.5 times the upper limit of reference range (ULRR).\*
- •4\.Serum creatinine greater than 1\.5 times the upper limit of reference range (ULRR).\*
- •5\.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).\*
- •6\.Positive of hepatitis B, hepatitis C virus or HIV.
- •7\.Have more than one abnormal EKG, which is considered as clinically significant. \*
- •8\.History or evidence of heart, renal, hepatic disease, pneumonia, lung fibrosis pulmonary obstructive disease, bronchial asthma, dyslipidemia, hypertension or glaucoma.
- •9\.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
- •10\.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
Outcomes
Primary Outcomes
Not specified
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