Depressive Disorder, MajorPhase 1NCT02698553

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Extended-release Bupropion Hydrochloride Tablets in Chinese Healthy Volunteers

A Phase 1 study testing Bupropion HCl XL tablet 150mg and Bupropion HCl XL tablet 300mg in people with Depressive Disorder, Major, run by GlaxoSmithKline at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Depressive Disorder, Major
What is being tested?: Bupropion HCl XL tablet 150mg and Bupropion HCl XL tablet 300mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteChina
Study dates: 23 May 2016to 29 Jun 2016
Phase: Phase 1
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Able to actively communicate with the investigator and to complete the study-related documents; able to understand the contents of the Informed consent form (ICF) and to sign a written ICF prior to any study-specific procedures.
Males and females aged between 18 and 45 years inclusive, at the time of signing the informed consent.
Non-smoking healthy males and females as assessed by medical history and physical examination. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters which are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight>=50 kilograms (Kg) and Body mass index (BMI) 19.0 to 25.0 kg/square meter (m^2).
A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing and agrees to use the contraception methods during the study and until follow up contact.
Male subjects with female partners of child-bearing potential must agree to use the contraception methods during the study and until follow up contact.
ALT, ALP and total bilirubin =<1.5x upper limit of normal (ULN) (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs obtained over a brief recording period: QTc <450 milliseconds (msec) or QTc <480 msec in subjects with bundle branch block.

Who cannot join

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Drug or alcohol abuse or dependency within one year prior to enrolment. History of regular alcohol consumption within 6 months of the study, defined as: an average weekly intake of >14 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [ml]) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Unstable disease conditions; any laboratory measurements assessed by the investigator as clinically relevant (including electroencephalogram [EEG], ECG, haematology, biochemistry and urine analysis, etc.); any disorder that might interfere with the absorption, distribution, metabolism or excretion of the study drug; or in the investigator's opinion the disease may lead to safety concerns or interfere with the pharmacokinetics assessment.
Subjects with concurrent or previous neuropsychological disorders, as assessed by Columbia Suicidality Severity Rating (CSSR) Scale or by the investigator, have suicidal tendency, or have committed suicidal behavior/attempt.
Known history of cerebral trauma, previous cerebral disorders, seizures or eating disorder, and other conditions that in the investigator's opinion may increase the risk of seizures.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of Other Criteria

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Serum human immunodeficiency virus (HIV) antibody or Syphilis antibody positive.
A positive pre-study drug/alcohol screen.
Blood donation in the 3 months prior to enrolment. Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.
Obvious evidence of active haematological diseases, or significant blood loss in the last 3 months. History of sensitivity to heparin or heparin-induced thrombocytopenia.
The subject has participated in a clinical trial and has received an investigational product within 30 days prior to the first dosing day in the current study.
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Known allergy to Bupropion Extended-Release Tablets or any of its components.
Lactating females or women of child bearing potential used oral or implanted contraceptives within the 30 days prior to enrolment, or received injections of chronically acting contraceptives in the 1 year prior to study initiation.
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.
Other conditions which, in the Investigator's judgment, render subjects unsuitable for the clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

GSK Investigational Site
Shanghai, 200030

Other trials in China

About this study

Official title: An Open-label, Fixed Sequence Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeated Dose of Extended-release Bupropion Hydrochloride (Bupropion XL) Tablets 150 mg and 300 mg Once Daily in Chinese Healthy Volunteers

Bupropion is used in psychological disorder mainly in major depressive disorder (MDD). In China, buproprion Immediate Release (IR) and Sustained Release (SR) tablet have been in market for the treatment of MDD. Bupropion Hydrochloride (HCl) Extended Release (XL) tablets formulation is proposed for marketing approval in China for same indication. Therefore, a pharmacokinetic study is planned to be conducted in Chinese subjects. It is an open label, single-centre and single cycle study to evaluate the pharmacokinetics, safety and tolerability of 150 milligram (mg) and 300 mg following single and repeated daily doses. Approximately 16 males and females Chinese healthy subjects will be enrolled into the study to get 12 completed subjects.

Conditions: Depressive Disorder, Major
Being tested: Bupropion HCl XL tablet 150mg, Bupropion HCl XL tablet 300mg
Keywords: Major depressive disorder, Extended release Bupropion
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupropion HCl XL tablet 150mgDrug
The 150 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.
Bupropion HCl XL tablet 300mgDrug
The 300 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.

Study groups in NCT02698553
Study group	Role	What they receive
Bupropion XL once daily	Experimental	Healthy subjects will receive Bupropion XL 150milligram (mg) once daily for 5 days (Day 1 to Day 5) and then Bupropion XL 300 mg once daily from Day 6 to Day 14. Receives: Drug: Bupropion HCl XL tablet 150mg; Drug: Bupropion HCl XL tablet 300mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Time taken to reach peak plasma concentration (Tmax) of Bupropion HCl and its metabolites after single dose.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 hour (h) post dose.
Measured: Day 1 and Day 2.
Maximum observed concentration (Cmax) in plasma of Bupropion HCl and its metabolites after single dose.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Measured: Day 1 and Day 2.
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC [0-24]) of Bupropion HCl and its metabolites after single dose.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Measured: Day 1 and Day 2.
Tmax in plasma of Bupropion HCl and its metabolites after repeated doses
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively. Blood sample will be also collected at pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after 300 mg dose (Day 14 to 19).
Measured: Day 5 to Day 19 .
Steady state concentration (Css)-Css Minimum (Css_min), Css Maximum (Css_max), Average Css (Css_av) in plasma of Bupropion HCl and its metabolites after repeated dose.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Measured: Day 5 to Day 19.
Elimination half-life (t ½) in plasma of Bupropion HCl and its metabolites after repeated dose.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Measured: Day 5 to Day 19.
Apparent clearance (CL/F) in plasma of Bupropion HCl and its metabolites after repeated dose.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after last 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Measured: Day 5 to Day 19.
Area under the concentration-time curve over the dosing interval (AUC [0-tau]) in plasma of Bupropion HCl and its metabolites after repeated dose.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Measured: Day 5 to Day 19.

Secondary outcomes (8)

Number of subjects with adverse event (AE) and serious adverse event (SAE).
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment will be categorized as SAE.
Measured: Up to Day 33.
Number of subjects with abnormal Haematology parameters as a measure of safety.
Blood sample will be collected at screening, Day 1, Day 6 and Day 19 to assess platelet counts, red blood cells (RBC) count, haemoglobin, hematocrit, white blood cells (WBC) count, reticulocyte count, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), composite of WBC differential counts.
Measured: Up to Day 19.
Number of subjects with abnormal Clinical chemistry parameters as a measure of safety.
Blood sample will be collected at screening, Day 1, Day 6 and Day 19 to analyze blood urea nitrogen (BUN), creatinine, lactate dehydrogenase (LDH), urea, glucose level (fasting), composite electrolytes levels, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), alkaline phosphatase (ALP) levels, total cholesterol, total and direct bilirubin, uric acid, total protein and albumin levels.
Measured: Up to Day 19.
Number of subjects with abnormal Urinalysis parameters as a measure of safety assessed by dipstick test.
Urine sample will be collected at screening, Day 1, Day 6 and Day 19 to analyze specific gravity, pH, glucose, protein, blood and ketone bodies, and microscopic examination.
Measured: Up to Day 19.
Body temperature assessment as a safety measure.
Body temperature will be measured at screening, Day 0, Day 4 and Day 13 and sometimes when clinically indicated.
Measured: Day 0 to Day 13.
Blood pressure assessment as a safety measure.
Clinostatic hypertension (CH) will be measured which is defined as a group of patients presenting an increase in arterial blood pressure when supine and a concurrent decrease of at least 20 millimetre of mercury (mm Hg) of Systolic blood pressure (SBP) and/or at least 10 mm Hg of Diastolic blood pressure (DBP) upon standing. SBP and DBP will be measured pre-dosing and at 2, 4, 8h post-dosing on Day 1; pre-dosing and at 2, 5, 8h post-dosing on Day 6; after discharge on Day 2, 7 and 16; post dosing on the Day 3, 5, 9, 11, 14 and 19 or early withdraw from the study.
Measured: Day 1 to Day 19.
Heart rate assessment as a safety measure.
Heart rate will be measured pre-dosing and at 2, 4, 8h post-dosing on Day 1; pre-dosing and at 2, 5, 8h post-dosing on Day 6; after discharge on Day 2, 7 and 16; post dosing on the Day 3, 5, 9, 11, 14 and 19 or early withdraw from the study.
Measured: Day 1 to Day 19.
Electrocardiogram (ECG) assessment as a measure of safety and tolerability.
12-lead ECGs will be obtained.
Measured: Screening and Day 19.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 201629 Jun 2016

First posted3 Mar 2016 (estimated)
Study start23 May 2016
Primary completion29 Jun 2016
Study completion29 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02698553
Sponsor's protocol ID: 114883
Status last verified: Sep 2018
First submitted: 29 Feb 2016
Last updated: 13 Sep 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Zhang F, Li Y, Hu J, Zhong J, Li H. Population Pharmacokinetics, Safety and Tolerability of Extended-Release Bupropion and Its Three Metabolites in Chinese Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2019 Jun;44(3):339-352. doi: 10.1007/s13318-018-0537-z.
PubMed 30520001

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Fixed Sequence Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeated Dose of Extended-release Bupropion Hydrochloride (Bupropion XL) Tablets 150 mg and 300 mg Once Daily in Chinese Healthy Volunteers
ClinicalTrials.gov ID: NCT02698553
Acronym / sponsor ID: 114883
Conditions: Depressive Disorder, Major
Keywords: Major depressive disorder, Extended release Bupropion
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 May 2016 (actual)
Primary completion: 29 Jun 2016 (actual)
Study completion: 29 Jun 2016 (actual)
First posted: 3 Mar 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bupropion XL once daily	Experimental	Drug: Bupropion HCl XL tablet 150mg, Drug: Bupropion HCl XL tablet 300mgHealthy subjects will receive Bupropion XL 150milligram (mg) once daily for 5 days (Day 1 to Day 5) and then Bupropion XL 300 mg once daily from Day 6 to Day 14.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Able to actively communicate with the investigator and to complete the study-related documents; able to understand the contents of the Informed consent form (ICF) and to sign a written ICF prior to any study-specific procedures.
Males and females aged between 18 and 45 years inclusive, at the time of signing the informed consent.
Non-smoking healthy males and females as assessed by medical history and physical examination. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters which are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight>=50 kilograms (Kg) and Body mass index (BMI) 19.0 to 25.0 kg/square meter (m^2).
A female subject is eligible to participate if she is of: Child-bearing potential with negative pregnancy test as determined by serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing and agrees to use the contraception methods during the study and until follow up contact.

Key exclusion criteria (16 listed)

Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Drug or alcohol abuse or dependency within one year prior to enrolment. History of regular alcohol consumption within 6 months of the study, defined as: an average weekly intake of >14 drinks. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [ml]) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Unstable disease conditions; any laboratory measurements assessed by the investigator as clinically relevant (including electroencephalogram [EEG], ECG, haematology, biochemistry and urine analysis, etc.); any disorder that might interfere with the absorption, distribution, metabolism or excretion of the study drug; or in the investigator's opinion the disease may lead to safety concerns or interfere with the pharmacokinetics assessment.
Subjects with concurrent or previous neuropsychological disorders, as assessed by Columbia Suicidality Severity Rating (CSSR) Scale or by the investigator, have suicidal tendency, or have committed suicidal behavior/attempt.
Known history of cerebral trauma, previous cerebral disorders, seizures or eating disorder, and other conditions that in the investigator's opinion may increase the risk of seizures.

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
Bupropion HCl XL tablet 150mgThe 150 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.	Drug	Bupropion XL once daily
Bupropion HCl XL tablet 300mgThe 300 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.	Drug	Bupropion XL once daily

Primary outcome

Time taken to reach peak plasma concentration (Tmax) of Bupropion HCl and its metabolites after single dose.
Time frame: Day 1 and Day 2.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 hour (h) post dose.
Maximum observed concentration (Cmax) in plasma of Bupropion HCl and its metabolites after single dose.
Time frame: Day 1 and Day 2.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC [0-24]) of Bupropion HCl and its metabolites after single dose.
Time frame: Day 1 and Day 2.
Blood sample will be collected at pre-dosing, and 2, 3, 4, 5, 6, 8, 12, 16, and 24 h post dose.
Tmax in plasma of Bupropion HCl and its metabolites after repeated doses
Time frame: Day 5 to Day 19 .
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively. Blood sample will be also collected at pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after 300 mg dose (Day 14 to 19).
Steady state concentration (Css)-Css Minimum (Css_min), Css Maximum (Css_max), Average Css (Css_av) in plasma of Bupropion HCl and its metabolites after repeated dose.
Time frame: Day 5 to Day 19.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Elimination half-life (t ½) in plasma of Bupropion HCl and its metabolites after repeated dose.
Time frame: Day 5 to Day 19.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Apparent clearance (CL/F) in plasma of Bupropion HCl and its metabolites after repeated dose.
Time frame: Day 5 to Day 19.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after last 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).
Area under the concentration-time curve over the dosing interval (AUC [0-tau]) in plasma of Bupropion HCl and its metabolites after repeated dose.
Time frame: Day 5 to Day 19.
Blood sample will be collected at pre-dosing, and 2, 5, 8 and 12 h post dose after 150 mg dose (Day 5) and first 300 mg (Day 6) dose respectively, and pre-dosing, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 and 120 h post dose after last 300 mg dose (Day 14 to 19).

8 secondary outcomes

Number of subjects with adverse event (AE) and serious adverse event (SAE).
Time frame: Up to Day 33.
Number of subjects with abnormal Haematology parameters as a measure of safety.
Time frame: Up to Day 19.
Number of subjects with abnormal Clinical chemistry parameters as a measure of safety.
Time frame: Up to Day 19.
Number of subjects with abnormal Urinalysis parameters as a measure of safety assessed by dipstick test.
Time frame: Up to Day 19.
Body temperature assessment as a safety measure.
Time frame: Day 0 to Day 13.
Blood pressure assessment as a safety measure.
Time frame: Day 1 to Day 19.
Heart rate assessment as a safety measure.
Time frame: Day 1 to Day 19.
Electrocardiogram (ECG) assessment as a measure of safety and tolerability.
Time frame: Screening and Day 19.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
Derived from this study: PubMed 30520001Zhang F, Li Y, Hu J, Zhong J, Li H. Population Pharmacokinetics, Safety and Tolerability of Extended-Release Bupropion and Its Three Metabolites in Chinese Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2019 Jun;44(3):339-352. doi: 10.1007/s13318-018-0537-z.
Results for study 114883 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bupropion HCl XL tablet 150mg and Bupropion HCl XL tablet 300mg in people with Depressive Disorder, Major, run by GlaxoSmithKline 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 13 Sep 2018. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time taken to reach peak plasma concentration (Tmax) of Bupropion HCl and its metabolites after single dose. (time frame: Day 1 and Day 2.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698553, which also lists 1 linked publication.

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 13 Sep 2018.