Two-way Crossover, Single Dose Randomized, Two-stage Bioequivalence of Ketoprofen Lysine Salt Immediate Release vs Granules Oral Solution

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The present bioequivalence phase I study is needed to compare the bioavailability and the concentration-time profile of the new immediate release formulation of KLS 40 mg with the reference compound OKi®, ketoprofen lysine salt 80 mg granules for oral solution (bipartite sachets).

The objective of the study is to investigate the bioequivalence between two formulations containing ketoprofen lysine salt (KLS) when administered as single oral dose in two consecutive study periods to healthy male and female volunteers under fasting conditions.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A
• Collaborator: Cross Research S.A.
• Treatments: Ketoprofen; Ketoprofen lysine; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

To be enrolled in this study, subjects must fulfil all these criteria:

1. Informed consent: signed written informed consent before inclusion in the study

2. Sex and Age: males/females, 18-55 years old inclusive

3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive

4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 50-89 mmHg, pulse rate (PR) 50-90 bpm and body temperature (BT) ≤ 37.5° C, measured after 5 min of rest in the sitting position;

5. 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

6. 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, transdermal, or injectable contraceptives for at least 2 months before the screening visit

• A non-hormonal intrauterine device [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.

Exclusion Criteria:

Subjects meeting any of these criteria will not be enrolled in the study:

1. Electrocardiogram (ECG 12-leads, supine position): clinically significant abnormalities

2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study

3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness

4. 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

5. 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

6. Medications: medications, including over the counter (OTC) drugs [in particular ketoprofen and acetylsalicylic acid (ASA) and NSAIDs in general], herbal remedies and food supplements taken 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed

7. 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)

8. Blood donation: blood donations for 3 months before this study

9. 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 2010 (6)], caffeine (> 5 cups coffee/tea/day) or tobacco abuse (≥ 6 cigarettes/day)

10. Drug test: positive result at the drug test at screening

11. Alcohol test: positive alcohol breath test at day -1

12. Diet: abnormal diets (< 1600 or > 3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians

13. Pregnancy (females only): positive or missing pregnancy test at screening or day -1, pregnant or lactating women