BioequivalenceNCT05076474
Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg
A study testing Orlistat 60mg Cap in people with Bioequivalence, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Orlistat 60mg Cap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Mar 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a) Non-smoker, normal, healthy, adult human volunteers with regular bowel movement daily between 18 and 40 years of age (both inclusive).
- Having a Body Mass Index (BMI) between 19.0 and 26.0 (both inclusive), calculated as weight in kg/height in m2 and body weight ≥ 50 kg.
- Not having significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination, laboratory evaluations, 12 lead ECG, and chest X-ray recordings (P/A view).
- Able to understand and comply with the study procedures, in the opinion of the investigator.
- Able to give voluntary written informed consent for participation in the trial.
- Subjects willing to stay In house for the entire study duration. g) In case of female subjects: Surgically sterilized at least 6 months prior to study participation, Or If of childbearing potential is willing to use a suitable and effective double barrier contraceptive method or intra uterine device during the study.
- And Serum pregnancy test must be negative.
Who cannot join
- a) Known hypersensitivity to orlistat or to any of the excipients of drug. b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of a medicine (including vitamin preparation, herbal remedies, OTC or prescriptions) at any time within 14 days prior to first day of run-in period. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
- Consumption of Grapefruits or grapefruit products within a period of 72 hours prior to receiving the study drug of period-I.
- A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week for men and more than 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc.) or Consumption of alcohol or alcoholic products within 48 hours prior to first day of run-in period.
- Smokers, or who have smoked within last six months prior to start of the study.
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- Difficulty in swallowing solids dosage forms like tablets or capsules. i) The presence of clinically significant abnormal laboratory values during screening.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- History or presence of psychiatric disorders. l) A history of difficulty with donating blood. m) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
- Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication**.
- If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
- A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
- A positive test result for HIV antibody (1 \&/or 2). q) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to first day of run-in period. In any such case subject selection will be at the discretion of the Principal Investigator.
- Nursing mothers (for female subjects).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Randomized, Three-treatment, Three-period, Three-sequence, Multiple Dose, Crossover, Comparative Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg In Normal, Healthy, Adult, Human Subjects Under Fed Conditions
The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion.
After run-in period, subjects will be randomized to receive either test or reference orlistat formulations (60 mg or 120 mg) thrice daily under fed conditions for 10 consecutive days.
Read the detailed description
To assess the pharmacodynamic equivalence of orlistat, using fat excreted in feces, from sponsor's test product relative to that of reference product in normal, healthy, adult, human subjects under fed conditions.
- Conditions
- Bioequivalence
- Being tested
- Orlistat 60mg Cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlistat 60mg CapDrug
Also called Alli Orlistat 60mg Cap, Alli Orlistat 120mg Cap
Subjects completed a 5-day run-in period (baseline) and then were randomized to receive the first of 3 treatments; each treatment period lasted 10 days followed by a 4-day washout period between treatments.
| Study group | Role | What they receive |
|---|---|---|
| TR1R2 | Experimental | T(Orlistat 60-mg) R1(Alli 60-mg) R2（Alli 60-mg×2） Receives: Drug: Orlistat 60mg Cap |
| R2TR1 | Experimental | R2（Alli 60-mg×2） T(Orlistat 60-mg) R1(Alli 60-mg) Receives: Drug: Orlistat 60mg Cap |
| R1R2T | Experimental | R1(Alli 60-mg) R2（Alli 60-mg×2） T(Orlistat 60-mg) Receives: Drug: Orlistat 60mg Cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion over 24 hours
FFE24= 24h fecal fat content (g)/daily fat (g) *100%
Measured: 3days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Oct 2020
- Primary completion1 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin Li, Doctor, Principal investigator, Changsha Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076474
- Sponsor's protocol ID
- NTP-SEJ-C-BE01
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized, Three-treatment, Three-period, Three-sequence, Multiple Dose, Crossover, Comparative Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg In Normal, Healthy, Adult, Human Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT05076474
- Acronym / sponsor ID
- NTP-SEJ-C-BE01
- Conditions
- Bioequivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 13 Oct 2021 (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 study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion.
After run-in period, subjects will be randomized to receive either test or reference orlistat formulations (60 mg or 120 mg) thrice daily under fed conditions for 10 consecutive days.
Detailed description
To assess the pharmacodynamic equivalence of orlistat, using fat excreted in feces, from sponsor's test product relative to that of reference product in normal, healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TR1R2 | Experimental | Drug: Orlistat 60mg CapT(Orlistat 60-mg) R1(Alli 60-mg) R2（Alli 60-mg×2） |
| R2TR1 | Experimental | Drug: Orlistat 60mg CapR2（Alli 60-mg×2） T(Orlistat 60-mg) R1(Alli 60-mg) |
| R1R2T | Experimental | Drug: Orlistat 60mg CapR1(Alli 60-mg) R2（Alli 60-mg×2） T(Orlistat 60-mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a) Non-smoker, normal, healthy, adult human volunteers with regular bowel movement daily between 18 and 40 years of age (both inclusive).
- And Serum pregnancy test must be negative.
Key exclusion criteria (14 listed)
- a) Known hypersensitivity to orlistat or to any of the excipients of drug. b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, subject can be included considering 10 half-lives duration of investigational medicinal product received.
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 |
|---|---|---|
| Orlistat 60mg CapAlso: Alli Orlistat 60mg Cap, Alli Orlistat 120mg CapSubjects completed a 5-day run-in period (baseline) and then were randomized to receive the first of 3 treatments; each treatment period lasted 10 days followed by a 4-day washout period between treatments. | Drug | R1R2T, R2TR1, TR1R2 |
Primary outcome
Fecal fat excretion over 24 hours
Time frame: 3days
FFE24= 24h fecal fat content (g)/daily fat (g) *100%
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 Oct 2021.
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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.
Xin Li, Doctor principal investigator
Changsha Third 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 Orlistat 60mg Cap in people with Bioequivalence, run by Shandong New Time Pharmaceutical Co., LTD 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 7 inclusion and 14 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 Oct 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 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?
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?
Fecal fat excretion over 24 hours (time frame: 3days). 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 13 Oct 2021.