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
Overview
- Phase
- Phase 1
- Intervention
- SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)
- Conditions
- Healthy Volunteers
- Sponsor
- Solasia Pharma K.K.
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- AUC0-∞
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Group 1 (SP-01-K)
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
Intervention: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)
Group 1 (SP-01-K)
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
Intervention: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
Group 2 (SP-01-A)
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
Intervention: SP-01 manufactured by Site K (SP-01-K, Transdermal patch contained granisetron)
Group 2 (SP-01-A)
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
Intervention: SP-01 manufactured by Site A (SP-01-A, Transdermal patch contained granisetron)
Outcomes
Primary Outcomes
AUC0-∞
Time Frame: 11 days
Area under the plasma concentration-time curve from time zero to time infinity
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
Maximum observed drug concentration (Cmax)
Time Frame: 11 days
Maximum observed drug concentration in plasma
Secondary Outcomes
- Adverse event(38 days)
- Adhesion(7 days)
- Time to reach Cmax (Tmax)(11 days)
- Terminal elimination rate constant (λZ)(11 days)
- Elimination half-life (t1/2)(11 days)