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

NCT05075876 | Completed Phase 1

• 1 other identifier: SP-0105
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed drug concentration (Cmax)

  Maximum observed drug concentration in plasma

  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

  11 days

• AUC0-∞

  Area under the plasma concentration-time curve from time zero to time infinity

  11 days

Secondary Outcomes (5)

• Time to reach Cmax (Tmax)

  11 days

• Terminal elimination rate constant (λZ)

  11 days

• Elimination half-life (t1/2)

  11 days

• Adverse event

  38 days

• Adhesion

  7 days

Study Arms (2)

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

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

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)

Interventions

SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron) DRUG

Single application for 6 days

Group 1 (SP-01-K); Group 2 (SP-01-A)

SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron) DRUG

Single application for 6 days

Group 1 (SP-01-K); Group 2 (SP-01-A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Solasia Pharma K.K.: lead

Study Sites (1)

Phase 1 Clinical Trials Centre, The University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Bernard Man Yung Cheung

  Phase 1 Clinical Trials Centre, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 13, 2021
• Study Start: October 13, 2021
• Primary Completion: December 3, 2021
• Study Completion: December 3, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)