Comparative bioavailability study of Test product Alogliptin and Pioglitazone tablets 12.5 mg/45 mg compared with the reference product of Oseni (alogliptin and pioglitazone) tablets 12.5 mg/ 45 mg, in healthy, adult, human subjects, under fed conditions.
- Registration Number
- CTRI/2019/04/018646
- Lead Sponsor
- Indoco Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy human subjects within the age range of 18 to 45 years (both inclusive).
2.Willing to abstain from use of any prescription and over the counter medications (vitamins and minerals through duration of the study) including medications which may interfere with pharmacokinetics of Alogliptin and Pioglitazone.
3.Willingness to provide written informed consent to participate in the study.
4.Body-mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2, with body weight not less than 50 kg.
5.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
6.Normal 12-lead ECG or one with abnormality considered to be clinically insignificant.
7.Normal chest X-ray PA view.
8.Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
9.Female Subjects
9.1 Subject having negative serum β-hCG test (only for female volunteers).
9.2 of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or.
9.3 post-menopausal for at least 1 year, or.
9.4 surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
1.Personal / family history of allergy or hypersensitivity to Alogliptin, Pioglitazone & its excipients and related drugs.
2.Past history of anaphylaxis or angioedema or severe cutaneous adverse reactions.
3.History or presence of bronchial asthma.
4.History or presence of smoking more than 10 cigarettes per day.
5.Presence of drug abuse.
6.History of major illness in the past three months or any clinically significant on-going chronic medical illness e.g., congestive heart failure, hepatitis, pancreatitis etc.
7.Known or suspected increased susceptibility to infection.
8.Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
9.History of cardiac, renal or liver disease resulting in liver impairment, any other organ or system impairment.
10.History of seizure or psychiatric disorders.
11.Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus.
12.Significant alcohol consumption for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit].
13.Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate) within 48 hours before check-in.
14.History of any usage of recreational drug or a history of drug addiction.
15.History of participation in any clinical trial within the past 3 months.
16.Inaccessibility of veins in left and right arm.
17.History of donation of blood (one unit or 330 mL) within 3 months prior to check-in.
18.Use of any prescribed or OTC medicinal products including vitamins and minerals during the within two weeks prior to investigational products administration in period I.
19.History of unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to check-in.
20.History of consumption of grapefruit- containing food or beverages within 48 hours prior to the check-in.
21.Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to check-in.
22.Female volunteers demonstrating a positive test for pregnancy during screening or currently breast-feeding.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the single oral dose bioequivalence of test product of Alogliptin and Pioglitazone tablets 12.5 mg/45 mg of Indoco Remedies Limited, India with that of reference product Oseni (alogliptin and pioglitazone) tablets 12.5 mg/ 45 mg of Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015 in healthy, adult, human subjects under fed conditions. <br/ ><br>Plasma PK parameters including Cmax AUC0-t and AUC0-â?? for Lacosamide in relevant treatmentsTimepoint: A pre-dose blood sample (0.00 hours) will be collected within 90 minutes before dosing in study period. <br/ ><br> <br/ ><br>Single venous blood sample will be withdrawn at pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.33, 4.67, 5.00, 5.33, 5.67, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose
- Secondary Outcome Measures
Name Time Method To characterise secondary PK parameters of two test product Alogliptin and Pioglitazone tablets 12.5 mg/45 mg with that of reference product Oseni (alogliptin and pioglitazone) tablets 12.5 mg/ 45 mg in healthy human subjects under fed conditions. <br/ ><br> <br/ ><br>Plasma PK parameters: Tmax, t1/2, Kel and AUC_% Extrap_Timepoint: Single venous blood sample will be withdrawn at pre-dose (0.00) and 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.33, 4.67, 5.00, 5.33, 5.67, 6.00, 6.50, 7.00, 7.50, 8.00, 9.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours post-dose