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

NCT04229602 | Unknown

• 1 other identifier: FY-CP-06-201909-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioequivalence Study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Venlafaxine Hydrochloride Sustained-Release Capsules

EXPERIMENTAL

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

Active Comparator: EFEXOR® XR

ACTIVE COMPARATOR

During the study session, healthy subjects will be administered a single dose of EFEXOR® XR 75mg under Fed conditions.

Drug: EFEXOR® XR

Interventions

Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg DRUG

A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.

Venlafaxine Hydrochloride Sustained-Release Capsules

EFEXOR® XR DRUG

EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD)

Active Comparator: EFEXOR® XR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects enroll in other clinical trials and take corresponding experimental drugs within 90 days before the trial, or participate in other clinical trials;
• 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;
• 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;
• Any history of surgery or trauma that may affect the safety of the test or the in-vivo process of the drug;;
• Subjects have depression, mania and other mental disorders, or have suicidal tendencies;
• Subjects have the history of angle-closure glaucoma;
• 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;
• Subjects had taken any alcoholic product within 24 hours before the test, or had tested positive for alcohol breath test;
• 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);
• Lactose intolerance (a history of diarrhea from drinking milk);
• Previous history of drug use, drug abuse, or positive urine drug screening;
• 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;
• Nursing woman;
• 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;
• Subjects who have taken any medicine (including Chinese herbal medicine) and health care products within 14 days before the test;

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Institution of Drug Clinical Trials

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Venlafaxine Hydrochloride

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Officials

• Xiuli Zhao, Dr

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wu, Dr

CONTACT

0086-10-58268486; trdrug@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 18, 2020
• Study Start: January 2, 2020
• Primary Completion: April 2, 2020
• Study Completion: July 2, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)