Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution

NCT04678076 | Completed Phase 1

• 2 other identifiers: 145(B)WO17389CRO-PK-18-326
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single dose, open-label, randomised, two period, two-way cross-over, two stage bioequivalenve study with the aim to investigate the bioequivalence between a new formulation of ketoprofen 25 mg versus OKI 80 mg granules for oral solution (half sachet), after single dose administration in two consecutive periods to healthy voluteers under fed conditions.

Conditions

Healthy

Keywords

ketoprofen; oral gel; ketoprofen Lysine Salt as granules; bioequivalence

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentration of ketoprofen

  to evaluate the rate (Cmax) of absorption of ketoprofen after single oral dose of test and reference.

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

• Area under the concentration-time curve 0-t

  to evaluate the extent (AUC0-t) of absorption after single oral dose of test and reference

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

Secondary Outcomes (7)

• Time to achieve Cmax

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

• t1/2

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

• tlag after single oral dose of test and reference products

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

• AUC0-∞ and residual area of ketoprofen derived from plasma concentrations after single oral dose of test and reference products;

  pre-dose (0), 20, 40 minutes, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours post-dose

• Treatment-Emergent Adverse Events

  through study completion, an average two weeks

Study Arms (2)

ketoprofen 25mg/5ml oral gel stick pack

EXPERIMENTAL

Single dose of ketoprofen 25mg/5ml oral gel stick pack will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Drug: Ketoprofen Lysine

OKi 80 mg granules for oral solution (bipartite sachet)

ACTIVE COMPARATOR

Single dose of half sachet containing 40 mg of ketoprofen lysine salt (corresponding to 25 mg as ketoprofen) will be administered to healthy volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Drug: Ketoprofen Oral Product

Interventions

Ketoprofen Lysine DRUG

A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

ketoprofen 25mg/5ml oral gel stick pack

Ketoprofen Oral Product DRUG

A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.

Also known as: OKI 80 mg

OKi 80 mg granules for oral solution (bipartite sachet)

Eligibility Criteria

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

You may qualify if:

• Sex and Age: males/females, 18-55 years old inclusive.
• Body Mass Index (BMI): 18.5-30 kg/m2 inclusive.
• Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg and heart rate 50-90 bpm, measured after 5 min of rest in the sitting position.
• Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
• Contraception and fertility (females only): females of child-bearing potential and with an active sexual life must be using at least one of the following reliable methods of contraception:
• Hormonal oral, implantable, intrauterine device \[IUD\], transdermal or injectable contraceptives for at least 2 months before the screening visit
• A non-hormonal IUD or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
• A male sexual partner who agrees to use a male condom with spermicide
• A sterile sexual partner
• Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, pregnancy test result must be negative at screening and day -1 of each study period.

You may not qualify if:

• Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities.
• Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study.
• Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness.
• Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study.
• Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory (including asthma), skin, haematological, endocrine or neurological and autoimmune diseases that may interfere with the aim of the study.
• Medications: medications, including over the counter (OTC) drugs \[in particular ketoprofen, acetylsalicylic acid (ASA) and NSAIDs in general\], herbal remedies and food supplements for 2 weeks before the start of the study. Paracetamol will be allowed as therapeutic counter-measure for adverse events (AEs) according to the Investigator's opinion. Hormonal contraceptives and hormone replacement therapies for females will be allowed.
• Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study (date of the informed consent signature).
• Blood donation: blood donations for 3 months before this study.
• Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\> 1 drink/day for females and \> 2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015-2020, caffeine (more of 5 cups coffee/tea/day) or tobacco abuse (more or equal of 6 cigarettes/day).
• Drug test: positive result at the drug test at screening or day -1 of each study period.
• Alcohol test: positive alcohol breath test at day -1 of each study period.
• Diet: abnormal diets (\< 1600 or \> 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians.
• Pregnancy (females only): positive or missing pregnancy test at screening or day -1 of each study period; pregnant or lactating women.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Cross Research S.A.: collaborator

Study Sites (1)

CROSS Research S.A., Phase I Unit,

Arzo, CH-6864, Switzerland

Location

MeSH Terms

Interventions

ketoprofen lysine

Study Officials

• Milko Radicioni, MD

  CROSS Research S.A., Phase I Unit, Via F.A. Giorgioli 14 CH-6864 Arzo, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking procedure will be applied.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose, open-label, randomised, two-period, two-way cross-over, two-stage bioequivalence study.

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 21, 2020
• Study Start: July 23, 2018
• Primary Completion: August 5, 2018
• Study Completion: August 5, 2018
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

CH (1)