Bioequivalence StudyNCT04229602
Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules in Chinese Healthy Volunteers
A study testing Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg and EFEXOR® XR in people with Bioequivalence Study, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the human bioequivalence of two Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study
- What is being tested?
- Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg and EFEXOR® XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2020to 2 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 21Show fewer
- 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;
- 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 ;
- 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;
- Subjects who have special requirements on diet and cannot accept unified diet;
- Subjects who have the difficulty in venous blood, or can not tolerate venipuncture, or have a history of dizziness;
- Subjects who need to drive and operate machines or engage in other potentially dangerous activities during the test;
- Other situations that the researchers considered unsuitable to enroll the subject.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institution of Drug Clinical Trials
Beijing, Beijing Municipality, 100730
Feng Wu, Dr, 0086-10-58268486, trdrug@126.com
About this study
Official title: 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) .
Read the 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.
- Conditions
- Bioequivalence Study
- Being tested
- Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg, EFEXOR® XR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venlafaxine Hydrochloride Sustained-Release Capsules 75 mgDrug
A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
EFEXOR® XRDrug
EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: EFEXOR® XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax
Cmax - Maximum Observed Concentration (of Venlafaxine in Plasma)
Measured: 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)
Measured: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-∞
AUC0-∞- Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Measured: Blood samples collected over 72 hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start2 Jan 2020
- Primary completion2 Apr 2020 (estimated)
- Study completion2 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioequivalence StudyStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, Dr, Principal investigator, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229602
- Sponsor's protocol ID
- FY-CP-06-201909-01
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Venlafaxine Hydrochloride Sustained-Release Capsules and EFEXOR® XR Under Fed Conditions in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04229602
- Acronym / sponsor ID
- FY-CP-06-201909-01
- Conditions
- Bioequivalence Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Apr 2020 (estimated)
- Study completion
- 2 Jul 2020 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the human bioequivalence of two Venlafaxine Hydrochloride Sustained-Release Capsules (75 mg) .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine Hydrochloride Sustained-Release Capsules | Experimental | Drug: Venlafaxine Hydrochloride Sustained-Release Capsules 75 mgDuring the study session, healthy subjects will be administered a single dose of Hydrochloride Sustained-Release Capsules 75 mg under Fed conditions. |
| Active Comparator: EFEXOR® XR | Active comparator | Drug: EFEXOR® XRDuring the study session, healthy subjects will be administered a single dose of EFEXOR® XR 75mg under Fed conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venlafaxine Hydrochloride Sustained-Release Capsules 75 mgA generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd. | Drug | Venlafaxine Hydrochloride Sustained-Release Capsules |
| EFEXOR® XREFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD) | Drug | Active Comparator: EFEXOR® XR |
Primary outcome
Bioequivalence based on Cmax
Time frame: Blood samples collected over 72 hour period
Cmax - Maximum Observed Concentration (of Venlafaxine in Plasma)
Bioequivalence based on AUC0-t
Time frame: Blood samples collected over 72 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Bioequivalence based on AUC0-∞
Time frame: Blood samples collected over 72 hour period
AUC0-∞- Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Zhao, Dr principal investigator
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg and EFEXOR® XR in people with Bioequivalence Study, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Wu, Dr (0086-10-58268486, trdrug@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence based on Cmax (time frame: Blood samples collected over 72 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.