Bioequivalence study of Fixed Dose Combination of Efonidipine HCl ethanolate 40 mg and Chlorthalidone 12.5 mg tablets in healthy adults.
- Registration Number
- CTRI/2020/03/023908
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
1. Healthy human subjects between 18 to 45 years of age (including both) and weight >= 50 kg (BMI 18.5 to 24.9 Kg/mm2 (including both)).
2. Acceptable findings during registration and screening including medical history, physical examinations, laboratory evaluations, 12-Lead ECG, and Chest X-Ray (postero-anterior view).
3. Values within normal ranges for laboratory parameters upon evaluation by the investigator or physician for any of the laboratory tests.
4. Subjects able to communicate effectively.
5. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
6. Subject willing to abstain from all kinds of caffeine/xanthine containing foods or alcoholic beverages, grapefruit or grapefruit juice from 72.00 hours prior to dosing until the last post dose blood sample collection in each period.
7. Must be non-smokers or ex-smokers: An ex-smoker is defined as someone who completely stopped smoking for atleast 6 months before Day 1 (first dosing) of Period- I of this study.
8. Female subjects:
- Postmenopausal for atleast 1 year or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject) or
- Female of childbearing 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, and intrauterine device (IUD) or abstinence.
1. Subjects having contraindication or hypersensitivity (e.g. anaphylaxis) to Efonidipine and Chlorthalidone or related group of drugs or any of its exicipients.
2. A history or presence of significant asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs, seizures, diabetes, migraine, hypertension, cardiovascular, pulmonary, neurological, or psychiatric disease/ disorder, dermatological, endocrine, immunological, hepatic, renal, hematopoietic, gastrointestinal, ongoing infectious diseases, or any other significant abnormality as evidenced by medical history and physical examination or according to the opinion of the physician.
3. History or presence of gastrointestinal inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine.
4. History or evidence of exfoliative dermatitis, Stevens Johnson syndrome, and toxic epidermal necrolysis.
5. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.
6. Participation in drug research study within 90 days prior to dosing of this study.
7. Blood loss or whole blood donation within 90 days prior to drug administration.
8. Consumption of high caffeine (more than 5 cups of coffee or tea/day).
9. History of addiction to any recreational drug or drug dependence.
10. Any unusual or abnormal diet for whatever reason within 48.00 hours prior to admission of each period, eg. fasting due to religious reasons.
11. History of dehydration from diarrhea, vomiting or any other reason within a period of 72.00 hours prior to study admission of each period.
12. Positive Results for drugs of abuse (benzodiazepine, cocaine, opioids, amphetamine, cannabinoids and barbiturates) in urine during the study admission of each period.
13. Positive results for alcohol breathe analysis during the study admission of each period.
14. History of pre-existing bleeding disorder.
15. Difficulty in swallowing solids like tablets
16. Difficulty with donating blood
17. Systolic blood pressure less than mm Hg or more than mm Hg.
18. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg
19. Pulse rate less than 60 beats/minute.
20. Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing
21. Female subjects demonstrating a positive pregnancy screen.
22. Female volunteer who is pregnant, currently breast-feeding.
23. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method