HealthyPhase 4NCT03711708
Relative Bioavailability Study of Zoloft Oral Solution to Zoloft Tablets
A Phase 4 study testing Zoloft Oral Solution and Zoloft tablets in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.
Trial summary
In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline. The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zoloft Oral Solution and Zoloft tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Nov 2018to 27 Feb 2019
- Phase
- Phase 4
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Female research subjects of non-childbearing potential
- Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight >50 kg (>110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the research subject has been informed of all pertinent aspects of the study.
- Research subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Clinically significant infections within the past 3 months, evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
- Evidence or history of cyclic neutropenia.
- Personal or family history of hereditary immunodeficiency (eg, severe combined immunodeficiency disorder [SCID], Wiskott Aldrich syndrome, X linked agammaglobulinemia).
- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing, or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of dosing.
- Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
Show all 25Show fewer
- Research subjects with a history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic).
- History of or current positive results for any of the following serological tests: hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti hepatitis C core antibody (HCV Ab), or human immunodeficiency virus (HIV) 1 and 2.
- A positive urine drug test.
- A positive alcohol screen.
- History of regular alcohol consumption exceeding 14 drinks/week for female research subjects or 21 drinks/week for male research subjects [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months before screening.
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 3 cigarettes, so research subjects would be limited to 2 or less chews per day.
- Treatment with an investigational drug within 6 months or 5 half lives preceding the first dose of investigational product (whichever is longer).
- Pregnant female research subjects, breastfeeding female research subjects, fertile male research subjects and female research subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol from at least 14 days prior to the first dose of investigational product until at least 28 days after the last dose of investigational product.
- A positive beta human chorionic gonadotropin test for women of childbearing potential.
- Use of prescription or nonprescription drugs and dietary supplements within 14 days or 5 half lives (whichever is longer) prior to the first dose of investigational product.
- Herbal supplements, hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone releasing intrauterine devices [IUDs], vaginal ring, and postcoital contraceptive methods), and hormone replacement therapy must have been discontinued at least 28 days prior to the first dose of investigational product.
- Depo Provera must have been discontinued at least 6 months prior to the first dose of investigational product.
- Consumption of grapefruit or grapefruit related citrus fruits (eg, Seville oranges, pomelos) or juices within 7 days prior to dosing.
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 3 months prior to screening.
- History of sensitivity to heparin or heparin induced thrombocytopenia.
- History of hypersensitivity to sertraline or any of the components in the formulation of the study products.
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the research subject inappropriate for entry into this study.
- Research subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or research subjects who are the sponsor's employees, including their family members, directly involved in the conduct of the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ICF - Instituto de Ciencias Farmaceuticas de Estudos e Pesquisas Ltda
Aparecida de Goiânia, Goiás, 74935-530
About this study
Official title: A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF ZOLOFT (REGISTERED) ORAL SOLUTION (20 MG/ML; FARMASIERRA MANUFACTURING, S.L.) COMPARED TO ZOLOFT (REGISTERED) TABLETS (50 MG; WYETH INDÚSTRIA FARMACÊUTICA LTDA.) IN HEALTHY RESEARCH SUBJECTS UNDER FASTED CONDITIONS
In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.
The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be palatable before use. The purpose of this study is to evaluate the relative bioavailability of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted conditions.
- Conditions
- Healthy
- Being tested
- Zoloft Oral Solution, Zoloft tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoloft Oral SolutionDrug
Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water
Zoloft tabletsDrug
Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Zoloft Oral Solution | Experimental | 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water. Receives: Drug: Zoloft Oral Solution |
| Zoloft Tablets | Active comparator | Zoloft 50 mg tablet. Receives: Drug: Zoloft tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the sertraline plasma concentration-time curve from time zero to last time point (AUClast)
Measured: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Maximum observed plasma concentration of sertraline (Cmax)
Measured: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Secondary outcomes (3)
Time to first occurrence of Cmax (Tmax) of sertraline
Measured: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Sertraline plasma elimination half life (t½)
Measured: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 144 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start6 Nov 2018
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711708
- Sponsor's protocol ID
- A0501107
- Status last verified
- Jan 2021
- First submitted
- 1 Oct 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE IV, SINGLE-DOSE, OPEN-LABEL, RANDOMIZED, 2-WAY CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF ZOLOFT (REGISTERED) ORAL SOLUTION (20 MG/ML; FARMASIERRA MANUFACTURING, S.L.) COMPARED TO ZOLOFT (REGISTERED) TABLETS (50 MG; WYETH INDÚSTRIA FARMACÊUTICA LTDA.) IN HEALTHY RESEARCH SUBJECTS UNDER FASTED CONDITIONS
- ClinicalTrials.gov ID
- NCT03711708
- Acronym / sponsor ID
- A0501107
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 18 Oct 2018 (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.
In Brazil, sertraline is currently available as film coated tablets for oral administration containing sertraline hydrochloride equivalent to 50 mg or 100 mg sertraline.
The sponsor has developed an oral solution formulation containing 20 mg/mL of sertraline, which must be diluted with 120 mL of water, ginger ale, lime/lemon soda or orange juice to be palatable before use. The purpose of this study is to evaluate the relative bioavailability of Zoloft oral solution compared to Zoloft tablets in healthy participants under fasted conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoloft Oral Solution | Experimental | Drug: Zoloft Oral Solution50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water. |
| Zoloft Tablets | Active comparator | Drug: Zoloft tabletsZoloft 50 mg tablet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy female research subjects and/or male research subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive.
- Female research subjects of non-childbearing potential
- Body mass index (BMI) of 18.5 kg/m2 to 24.9 kg/m2, and a total body weight >50 kg (>110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the research subject has been informed of all pertinent aspects of the study.
- Research subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (25 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- Clinically significant infections within the past 3 months, evidence of any infection within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
- Evidence or history of cyclic neutropenia.
- Personal or family history of hereditary immunodeficiency (eg, severe combined immunodeficiency disorder [SCID], Wiskott Aldrich syndrome, X linked agammaglobulinemia).
- Vaccination with live or attenuated vaccines within 6 weeks prior to dosing, or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of dosing.
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 |
|---|---|---|
| Zoloft Oral SolutionTest Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water | Drug | Zoloft Oral Solution |
| Zoloft tabletsReference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet | Drug | Zoloft Tablets |
Primary outcome
Area under the sertraline plasma concentration-time curve from time zero to last time point (AUClast)
Time frame: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Maximum observed plasma concentration of sertraline (Cmax)
Time frame: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
3 secondary outcomes
Time to first occurrence of Cmax (Tmax) of sertraline
Time frame: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Sertraline plasma elimination half life (t½)
Time frame: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Up to 144 hours post dose
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 27 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoloft Oral Solution and Zoloft tablets in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Brazil.
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 5 inclusion and 25 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 27 Jan 2021. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Area under the sertraline plasma concentration-time curve from time zero to last time point (AUClast) (time frame: Predose (0 h), at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 10, 12, 24, 48, 72, 96, 120, and 144 hours post dose). The study lists 2 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 27 Jan 2021.