BIOAVAILABILITY STUDY OF DAPAGLIFLOZIN 10 mg FORMULATIONS IN HEALTHY VOLUNTEERS UNDER FED CONDITIONS

Phase 1

Active, not recruiting

• Conditions: Healthy voluneers; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-005842-41-SI
• Lead Sponsor: KRKA, d.d., Novo mesto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Healthy male and female subjects aged between = 18 to = 55, Caucasian race.
2.Body mass index (weight/height²) in the range 18.5 to 30 kg/m².
3.Non-smokers or ex-smokers, where an ex-smoker is defined as someone who did not use nicotine/tobacco-containing products in the last 6 months prior to screening.
4.A female volunteer must meet one of the following criteria:
a) Participant is of childbearing potential and agrees to use one of the accepted contraceptive regiments from at least 28 days prior to the first administration of the study medication, during the study and for at least 30 days after the last dose of the study medication.
b) Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
5.Able to communicate and co-operate with the investigator and his staff.
6.Capable of consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects with positive answer to any of the following will not be eligible to enter the study:

At screening:
1.History of alcohol and/or drug abuse within one year prior to the screening.
2.Ongoing or history of clinically significant chronic illness (especially type 1 and type 2 diabetes mellitus, hypotension, genital or urinary tract infections).
3.Any clinically significant illness within 28 days prior to scheduled first administration of study medication.
4.Clinically significant abnormalities:
a.of medical history (especially diabetes, cardiac failure (including family history), hypotension, renal and hepatic impairment, conditions that may lead to increased risk of diabetic ketoacidosis, recent or recurrent history of diabetic ketoacidosis, perineal abscess, necrotising fasciitis of the perineum),
b.on physical examination (especially intercurrent conditions that may lead to volume depletion (e.g. gastrointestinal illness),
c.of the ECG,
d.of haematology, biochemistry or urinalysis results.
5.Positive test for HBsAg, anti-HCV, anti-HIV-1/HIV-2 at screening.
6.A depot injection or an implant of any drug (including hormone-releasing intrauterine device) within 90 days prior to scheduled first administration of study medication.
7.Participation in other clinical studies within 60 days prior to scheduled first administration of study medication.
8.Donation or loss of more than 450 mL of blood within 60 days, or donation of plasma or platelets within 14 days prior to scheduled first administration of study medication.
9.Seated diastolic blood pressure lower then 60 or higher than 90 mmHg , seated systolic blood pressure lower than 100 or higher than 140 mmHg.
10.Seated heart rate less than 55 or over 100 beats per minute.
11.Having a known sensitivity to study medications or any similar medications, including excipients.
12.Known history or presence of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
13.Use of any drugs known to induce or inhibit hepatic drug metabolism i.e. CYP3A4 inhibitors/inducers, CYP2D6 inhibitors (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 28 days prior to scheduled first administration of the study medication.
14.Clinically significant history or presence of any gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
15.Difficulties to swallow the study medication.
16.Unable or unwilling to comply with the provisions of this protocol.
17.Any reason which in opinion of the Medical Sub-investigator would prevent the volunteer from participating in the study.
18.For female subjects only: Females who use the following systemic contraceptives: oral, patch or vaginal ring, in the 28 days prior to scheduled first administration of study medication.
19.For female subjects only: Females who use hormone replacement therapy in the 28 days prior to scheduled first administration of study medication.
20.For female subjects only: Females who are pregnant or lactating.
21.For female subjects only: positive result of the serum pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified