Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules in Chinese Healthy Volunteers

Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules and EFEXOR® XR Under Fed Conditions in Chinese Healthy Volunteers

The objective of this study is to evaluate the human bioequivalence of two Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) .

Study Overview

• Status: Unknown
• Conditions: Bioequivalence Study
• Intervention / Treatment: Drug: Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg; Drug: EFEXOR® XR

Detailed Description

The objective of this study is to evaluate the human bioequivalence of Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) produced by Beijing Winsunny Pharmaceutical Co., Ltd and EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD), as well as the safety of the tested preparation, and to provide basis for the evaluation of the quality and efficacy consistency of the tested preparation and the reference preparation.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Wu, Dr; Phone Number: 0086-10-58268486; Email: trdrug@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Institution of Drug Clinical Trials
      • Contact: Feng Wu, Dr; Phone Number: 0086-10-58268486; Email: trdrug@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects are fully informed and voluntarily consent to participate in this study;
2. Healthy adult volunteers of ≥18 years old and ≤ 65 years old, male or female;
3. Body weight ≥ 50.0 kg for male and 45.0 kg for female;
4. Subjects are able to communicate well with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Subjects enroll in other clinical trials and take corresponding experimental drugs within 90 days before the trial, or participate in other clinical trials;
2. The results of physical examination, vital signs examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, coagulation function, immunity 8 items, blood pregnancy (female only)), 12-lead electrocardiogram (ECG) are clinical significant;
3. Any previous history and present medical history that may affect the safety of the trial or the in-vivo process of the drug, especially a history of liver, kidney, endocrine, cardiovascular, nervous, gastrointestinal, lung, tumor, immune, skin, blood or metabolic disorders that the investigator considers clinically significant;
4. Any history of surgery or trauma that may affect the safety of the test or the in-vivo process of the drug;;
5. Subjects have depression, mania and other mental disorders, or have suicidal tendencies;
6. Subjects have the history of angle-closure glaucoma;
7. Heavy smokers (average daily smoking of more than 5 cigarettes in the 90 days before the trial), heavy drinkers (average weekly drinking of more than 14 units of alcohol in the 90 days before the trial, 1 unit =360 mL beer or 45 mL 40% spirits or 150 mL wine), and subjects who could not promise to quit smoking and drinking during the experiment;
8. Subjects had taken any alcoholic product within 24 hours before the test, or had tested positive for alcohol breath test;
9. Allergic to any component of venlafaxine hydrochloride sustained-release capsules, or with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergic constitution (such as allergic to two or more drugs or food);
10. Lactose intolerance (a history of diarrhea from drinking milk);
11. Previous history of drug use, drug abuse, or positive urine drug screening;
12. Subjects who have donated blood or lost blood equal to or more than 200 mL within 90 days before the test, received blood transfusion or used blood products, or intend to donate blood or blood components during or within 3 months after the test;
13. Nursing woman;
14. Subjects planned parenthood, unwillingness or inability to use effective contraception, within 30 days before the trial (for women), and within six months after the end of the trial;
15. Subjects who have taken any medicine (including Chinese herbal medicine) and health care products within 14 days before the test;
16. Subjects who have taken any medicine that interacts with the drug or alters liver enzyme activity within 30 days prior to the trial, such as cimetidine, haloperidol, ketoconazole, clot-disrupting drugs (such as non-steroidal anti-inflammatory drugs, aspirin and warfarin), Monoamine oxidase inhibitors (such as phenyledrine, phenylamine, isazolid, isazolid, moclobemide, bromofaramine, nyalamide, tloxadone, defloxadone, slegiline, linezolid, or methylene blue for intravenous use), similar to other serotonin drugs (including triptans, selective serotonin reuptake inhibitors (SSRIs), other serotonin and norepinephrine reuptake inhibitors (SNRIs), lithium, sibutramine, tramadol or st John's wort, and tryptophan supplements) etc ;
17. Subjects who have eaten special diet (including grapefruit and/or food or drink rich in xanthine derivatives or alcohol, such as tea and coffee, etc.) or have other factors affecting drug absorption, distribution, metabolism and excretion within 14 days before the test;
18. Subjects who have special requirements on diet and cannot accept unified diet;
19. Subjects who have the difficulty in venous blood, or can not tolerate venipuncture, or have a history of dizziness;
20. Subjects who need to drive and operate machines or engage in other potentially dangerous activities during the test;
21. Other situations that the researchers considered unsuitable to enroll the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Venlafaxine Hydrochloride Sustained-Release Capsules; During the study session, healthy subjects will be administered a single dose of Hydrochloride Sustained-Release Capsules 75 mg under Fed conditions.	Drug: Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg; A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
Active Comparator: Active Comparator: EFEXOR® XR; During the study session, healthy subjects will be administered a single dose of EFEXOR® XR 75mg under Fed conditions.	Drug: EFEXOR® XR; EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence based on Cmax	Cmax - Maximum Observed Concentration (of Venlafaxine in Plasma)	Blood samples collected over 72 hour period
Bioequivalence based on AUC0-t	AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	Blood samples collected over 72 hour period
Bioequivalence based on AUC0-∞	AUC0-∞- Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	Blood samples collected over 72 hour period

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Xiuli Zhao, Dr, Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Anticipated): April 2, 2020
• Study Completion (Anticipated): July 2, 2020

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: FY-CP-06-201909-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No