A bioequivalence study of Efonidipine 40 mg and Chlorthalidone 12.5 mg tablet combination inhealthy adults.

Not Applicable

Completed

• Registration Number: CTRI/2021/03/032140
• Lead Sponsor: Zuventus Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-24
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

1. Healthy human subjects between 18-45 years of age (including both) and weight â�¥ 50 Kg (BMI 18.5 to 24.9 kg/m�² (including both)).

2. Acceptable findings during registration and screening including, medical history, physical examination, 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 following 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 alcoholic beverages, grapefruit/caffeine/xanthine containing foods or juices from at least 72.00 hours prior to admission until the last blood sample collection in each study period.

7. Must be non-smokers or ex-smokers: An ex-smoker is defined as someone who completely stopped smoking for at least 6 months before Day 1 (first dosing) of Period-I of this study.

8. Female subjects:

ïâ??· Postmenopausal for at least 1 year or

ïâ??· Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject) or

ïâ??· 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.

Exclusion Criteria

1. Subjects having contraindication or hypersensitivity (e.g., anaphylaxis) to Efonidipine and Chlorthalidone or related group of drugs or any of its excipients.

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 (GI) inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine.

4. History or evidence of exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).

5. Any known enzyme inducing or inhibiting drug taken within 30 days before the study.

6. Participation in a 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. An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g. 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 (benzodiazepines, cocaine, opioids, amphetamines, 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 120 mm Hg or more than 140 mm Hg.

18. Diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.

19. Pulse rate less than 60 beats/minute or more than 100 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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters Cmax, AUC0-72hr/AUC0-t and AUC0-inf of Efonidipine and Chlorthalidone from the test product to that of reference product will be assessed.Timepoint: Pre-dose (00.00 hour) and 00.50, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours post dose.

Secondary Outcome Measures

Name	Time	Method
Assessment of safety and tolerability of single oral dose of test and reference product.Timepoint: Through-out the study period;Pharmacokinetic parameters Tmax, T1/2, Kel and AUC_%Extrap_ of Efonidipine and <br/ ><br>Chlorthalidone from test products to that of reference product will be assessed.Timepoint: Pre-dose (00.00 hour) and 00.50, 01.00, 01.25, 01.50, 01.75, 02.00, 02.50, 03.00, 03.50, 04.00, 04.50, 05.00, 06.00, 08.00, 12.00, 24.00, 36.00, 48.00 and 72.00 hours post dose.