A single dose cross over oral bio equivalence study (celecoxib 100mg capsules) in normal, healthy,adult, human subjects under fed conditions.
- Registration Number
- CTRI/2021/02/031211
- Lead Sponsor
- PraNa Biosciences Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Subjects must fulfil all of the following criteria to be considered for inclusion into the study:
1.Healthy, adult, human subjects aged between 18 to 45 years (inclusive of both).
2.Body mass index between 18.50 kg/m2 to 30.0kg/m2(both inclusive) weight >= 45 kgs.
3.Healthy according to the laboratory results and physical examination, performed within 28 days prior to the commencement of the check-in in period-I.
4.Subjects having normal 12-lead electrocardiogram (ECG)
5.Subjects having normal chest X-Ray (P/A view)
6.Subjects able to communicate effectively.
7.Subjects willing to give written consent and adhere to all the requirements of this protocol.
8.Subjects willing to adhere to protocol requirements as evidenced by written informed consent approved by an ethics committee (EC).
9.If study subject is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s),such condoms, foams, jellies,diaphragm,intrauterine device(IUD), or abstinence:
OR
Is postmenopausal for at least 1 year.
OR
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the study subjects).
Subject will not be eligible for study participation if any of the following criteria is met:
1.History of contraindications or hypersensitivity to celecoxib or any of the excipients in the formulation.
2.Presence of urinary retention, gastric retention and uncontrolled narrow -angle glaucoma .
3.History or presence of any medical condition or disease according to the opinion of the physician.
4.History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
5.Subject who are on strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or inducers (e.g, rifampin, avasimibe,St johnâ??s wort,phenytoin,carbamazepine, etc.).
6.History of cholestatic jaundice/hepatic dysfunction.
7.History of exacerbations of symptoms of myasthenia gravis
8.History of presence of significant alcoholism or drug abuse in the past one year.
9.History of smoking (smokers and ex-smokers).
10.Difficulty with donating blood or difficulty in accessibility of veins.
11.History of dehydration from diarrhoea, vomiting or any other reason within a period of 24.00 hours prior to study check-in
12.An unusual or abnormal diet within 48.00 hours prior to study check-in., for whatever reason e.g. because of fasting due to religious reasons.
13.Difficulty in swallowing capsule.
14.Systolic blood pressure les than 90 mm Hg or more than 140 mm Hg.
15.Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
16.Pulse rate less than 60 beats /minute or more than 100 beats/minute.
17.Use of any prescribed medication during last two weeks or OTC medicinal products including herbal preparations, during the last two weeks preceding the first dosing.
18.Major illness during 90 days before screening.
19.Used any pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study.
20.Consumption of xanthine containing food and beverages (chocolates, tea, coffee, or cola drinks) and tobacco products for at least 48.00 hours prior to study check-in.
21.Participation in a drug research study within past 90 days.
22.Donation of blood in the past 90 days prior to study check-in of Period-I.
23.Consumption of poppy containing foods (like gasagasalu poppy containing products), grapefruit, mosumbi/sweet lime juice within the 7 days prior to study check-in.
24.Subjects with positive for breath alcohol test, urine screen for drugs of abuse (cannabinoids (marijuana / Tetra hydro cannabinoids-THC), cocaine, opiates, amphetamine, barbiturates, benzodiazepines) and urine hCG test (for female volunteers only) at the time of check-in for each period will be excluded from the study.
(In case of female participants)
1.Pregnant or lactating women
2.Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days) during past 6 months.
3. Unprotected sex with any nonsterile male partner within 14 days of drug administration during the entire duration of the study.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the oral relative bioequivalence of celecoxib 100 mg capsules in normal healthy adult human subjects under Fed conditions.Timepoint: 12 DAYS
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of a single dose of celecoxib 100 mg capsules in normal healthy adult human subjects under Fed conditions.Timepoint: 12 DAYS