Healthy VolunteersPhase 1NCT05075876

Bioequivalence Study in Healthy Chinese Subjects Comparing SP-01 (Granisetron Patch) Manufactured at Two Different Sites

A Phase 1 study testing SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron) and SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron) in people with Healthy Volunteers, run by Solasia Pharma K.K. at 1 site in Hong Kong.

Completed

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

Official record

Search all trials

Trial summary

This study is an open-label, single-center, two-period, two-sequence crossover study to assess the bioequivalence of SP-01 (Sancuso®: Granisetron Patch) manufactured at two different sites. Either the test product, namely SP-01-K, or reference product, namely SP-01-A, will be applied to the subject once in each period. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron) and SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteHong Kong
Study dates: 13 Oct 2021to 3 Dec 2021
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Han Chinese male or female subject, with all of his/her biological parents and grandparents are of Han Chinese ethnicity (who do not belong to any Chinese minorities)
Subject aged between 18 and 55 years, inclusive, at the time of signing the informed consent form
Body weight ≥ 45 kg and body mass index (BMI) of 18 to 25 kg/m2, inclusive.
Generally in good health with no clinically significant abnormality. Clinically insignificant abnormalities may be acceptable at the discretion of the investigator.
Female subject.
Non-childbearing potential

Show all 12Show fewer

For female subject of childbearing potential who used (and/have their partner used) two acceptable contraceptive methods for at least 4 weeks prior to the first dose of study drug, and agree to use two contraceptive methods during the entire study period and within 3 weeks after the patch removal in Period 2. If abstinence is an alternative lifestyle, subject who is practicing abstinence and agree to practice abstinence throughout the above-mentioned periods may be included into the study.
Male subject.
If male subject has a female partner with childbearing potential, he has used (or has his partner used) two acceptable contraceptive methods for at least 4 weeks prior to the first dose of study drug, and must agree to use (or has his partner used) two contraceptive methods during the entire study period and within 3 weeks after the patch removal in Period 2. If abstinence is an alternative lifestyle, subject who is practicing abstinence and agree to practice abstinence throughout the above-mentioned periods may be included into the study.
Ability to understand the nature, scope and possible consequences of participation in the study
Willing to comply with the study procedures and restrictions
Willing to give written informed consent voluntarily

Who cannot join

Known significant allergic conditions to any medications in general, or to transdermal therapeutic systems (e.g. Elastoplast®) or medical adhesive tapes/dressings in particular.
Concurrent clinically significant conditions or known history of clinically significant conditions including but not limited to hepatobiliary \& pancreatic, renal, urinary, respiratory, gastrointestinal, endocrine, cardiovascular, neurological, immunological, haematological, musculoskeletal, dermatological and/or psychiatric disorders.
Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula prior to the first dose of study drug.
Subject has abnormal Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values prior to the first dose of study drug and the abnormality, as determined by investigators, makes the subject not suitable for participation in the study.
Subject has history of uncontrollable migraine or headaches.
Subject has any skin conditions (e.g. tattoos, wounds, oily skin) or diseases (e.g. dermatological disorder) that may hinder clinical assessments on the upper lateral arm where the study drug is applied.

Show all 27Show fewer

Any conditions or illnesses that in the opinion of the Investigator may jeopardize subjects or interfere with the interpretation of study results.
Has used any prescribed or over-the-counter medication, vitamins, herbal supplements, vaccines, and/or hormonal contraceptive pill/patch/injection within 14-day period (use of acetaminophen/paracetamol as sole active ingredient within 7 days) prior to the first dosing of the study drug (Day 1). Exceptions include topical medications or eye drops with no systemic action.
Participation in any clinical studies which involve the use of investigational medicinal product(s) within 3 months prior to the first dose of study drug.
Blood loss or donation of more than 450 ml within 3 months prior to the first dose of study drug.
Female subject who is lactating or has positive pregnancy test result prior to the first dose of study drug.
Has not constantly resided in Hong Kong or with recent significant change in lifestyle and habits, including diet and exercise.
Engaged in strenuous exercise within 14 days prior to the first dose of study drug or unwilling to stop strenuous exercise throughout the entire duration of the study.
Refuse to refrain from swimming, prolonged soaking in water (e.g. bathing), sauna or activities that cause excessive sweating when wearing a study patch.
Refuse to refrain from activities such as sunbathing or tanning using tanning bed/sunlamps that expose the application site to direct sunlight when wearing a patch and within 10 days after the patch removal.
Refuse to avoid scrubbing and shaving the patch application site from 48 hours prior to patch application and when wearing a patch.
Refuse to avoid application of creams, lotions or oils to the patch application site from 48 hours prior to patch application and when wearing a patch.
Refuse to abstain from consuming grapefruit or grapefruit-containing beverages from 48 hours prior to the first patch application until the last PK blood sampling on Day 11 in each period
Regular consumption of large quantities of xanthine-containing beverages such as coffee, tea, chocolate, cola or other caffeinated beverages, defined as more than 6 cups per day within 3 months prior to signing informed consent.
Refuse to restrict the consumption of xanthine-containing beverages to a maximum of 2 cups per day during screening and Day 12 to Day 25 of period 1, and refuse to abstain from consuming xanthine-containing beverages from 48 hours prior to patch application until the last PK blood sampling on Day 11 in each period.
Regular consumption of alcoholic beverages that exceeds 14 units per week (1 unit = 360 ml of beer; 150 ml of wine; 45 ml of distilled spirits) within 3 months prior to signing informed consent.
Refuse to restrict the consumption of alcoholic beverages to a maximum of 1 unit per day during screening and Day 12 to Day 25 of period 1, and refuse to abstain from alcoholic beverages from 48 hours prior to patch application until the last PK blood sampling on Day 11 in each period.
Regular tobacco smoking or using nicotine containing product of more than 3 cigarettes per day within 3 months prior to signing informed consent.
Refuse to abstain from tobacco smoking or using nicotine containing product from screening until Day 11 of Period 2.
History of substance (alcohol or illicit drugs) abuse/addiction in the past 5 years, or used illicit drugs 3 months prior to signing informed consent, or positive urine drug test and blood alcohol test prior to the first dose of study drug.
Subject has an immediate family member (e.g. spouse, parent/legal guardian, sibling or child) who is the study site or sponsor staff and directly involved with this study.
Any other concerns that the Investigator considers the subject not suitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Phase 1 Clinical Trials Centre, The University of Hong Kong
Hong Kong

Other trials in Hong Kong

About this study

Official title: An Open-Label, Randomized, Single-Center, Two-period, Two-sequence Cross-over Study to Assess the Bioequivalence of a Single 6-day Application of SP-01 (Granisetron Patch) Manufactured at Two Different Sites in Healthy Chinese Subjects

Conditions: Healthy Volunteers
Being tested: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)

What participants receive

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

SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)Drug
Single application for 6 days
SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)Drug
Single application for 6 days

Study groups in NCT05075876
Study group	Role	What they receive
Group 1 (SP-01-K)	Experimental	Application of SP-01 manufactured by Site K (SP-01-K) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site A (SP-01-A) for 6 days Receives: Drug: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron); Drug: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
Group 2 (SP-01-A)	Active comparator	Application of SP-01 manufactured by Site A (SP-01-A) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site K (SP-01-K) for 6 days Receives: Drug: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron); Drug: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)

What is being measured

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

Maximum observed drug concentration (Cmax)
Maximum observed drug concentration in plasma
Measured: 11 days
Area under the concentration-time curve (AUC) 0-t
Area under the plasma concentration-time curve from time zero to time t, where t is the last time point with non-zero concentration
Measured: 11 days
AUC0-∞
Area under the plasma concentration-time curve from time zero to time infinity
Measured: 11 days

Secondary outcomes (5)

Time to reach Cmax (Tmax)
Time to reach the maximum observed drug concentration in plasma
Measured: 11 days
Terminal elimination rate constant (λZ)
Apparent terminal phase rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus time profile during the terminal phase
Measured: 11 days
Elimination half-life (t1/2)
The time required for the observed drug concentration in plasma to reach half of its original value
Measured: 11 days
Adverse event
Incidence of adverse events
Measured: 38 days
Adhesion
Mean adhesion score, which is the average of adhesion scores of a subject in a period
Measured: 7 days

Timeline

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

13 Oct 20213 Dec 2021

First posted13 Oct 2021
Study start13 Oct 2021
Primary completion3 Dec 2021
Study completion3 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05075876
Sponsor's protocol ID: SP-0105
Status last verified: Feb 2022
First submitted: 21 Sep 2021
Last updated: 9 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Randomized, Single-Center, Two-period, Two-sequence Cross-over Study to Assess the Bioequivalence of a Single 6-day Application of SP-01 (Granisetron Patch) Manufactured at Two Different Sites in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT05075876
Acronym / sponsor ID: SP-0105
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Solasia Pharma K.K.Industry (pharma, biotech, devices)
Study start: 13 Oct 2021 (actual)
Primary completion: 3 Dec 2021 (actual)
Study completion: 3 Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 (SP-01-K)	Experimental	Drug: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), Drug: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)Application of SP-01 manufactured by Site K (SP-01-K) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site A (SP-01-A) for 6 days
Group 2 (SP-01-A)	Active comparator	Drug: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron), Drug: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)Application of SP-01 manufactured by Site A (SP-01-A) for 6 days followed by washout period for 21 days followed by application of SP-01 manufactured by Site K (SP-01-K) for 6 days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Han Chinese male or female subject, with all of his/her biological parents and grandparents are of Han Chinese ethnicity (who do not belong to any Chinese minorities)
Subject aged between 18 and 55 years, inclusive, at the time of signing the informed consent form
Body weight ≥ 45 kg and body mass index (BMI) of 18 to 25 kg/m2, inclusive.
Generally in good health with no clinically significant abnormality. Clinically insignificant abnormalities may be acceptable at the discretion of the investigator.
Female subject.

Key exclusion criteria (27 listed)

Known significant allergic conditions to any medications in general, or to transdermal therapeutic systems (e.g. Elastoplast®) or medical adhesive tapes/dressings in particular.
Concurrent clinically significant conditions or known history of clinically significant conditions including but not limited to hepatobiliary \& pancreatic, renal, urinary, respiratory, gastrointestinal, endocrine, cardiovascular, neurological, immunological, haematological, musculoskeletal, dermatological and/or psychiatric disorders.
Subject has estimated creatinine clearance ≤ 80 mL/min calculated by Cockcroft Gault formula prior to the first dose of study drug.
Subject has abnormal Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values prior to the first dose of study drug and the abnormality, as determined by investigators, makes the subject not suitable for participation in the study.
Subject has history of uncontrollable migraine or headaches.

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
SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)Single application for 6 days	Drug	Group 1 (SP-01-K), Group 2 (SP-01-A)
SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)Single application for 6 days	Drug	Group 1 (SP-01-K), Group 2 (SP-01-A)

Primary outcome

Maximum observed drug concentration (Cmax)
Time frame: 11 days
Maximum observed drug concentration in plasma
Area under the concentration-time curve (AUC) 0-t
Time frame: 11 days
Area under the plasma concentration-time curve from time zero to time t, where t is the last time point with non-zero concentration
AUC0-∞
Time frame: 11 days
Area under the plasma concentration-time curve from time zero to time infinity

5 secondary outcomes

Time to reach Cmax (Tmax)
Time frame: 11 days
Terminal elimination rate constant (λZ)
Time frame: 11 days
Elimination half-life (t1/2)
Time frame: 11 days
Adverse event
Time frame: 38 days
Adhesion
Time frame: 7 days

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 9 Feb 2022.
Individual participant dataSharing planned: No

Related trials for Healthy Volunteers

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
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

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.

Bernard Man Yung Cheung principal investigator

Phase 1 Clinical Trials Centre, The University of Hong Kong

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

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 27 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 9 Feb 2022. 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 Hong Kong. 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?

Maximum observed drug concentration (Cmax) (time frame: 11 days). 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?

On the ClinicalTrials.gov record for NCT05075876.

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 9 Feb 2022.