Bioequivalence study of Nisoldipine 34mg ER oral tablet

Not Applicable

• Registration Number: CTRI/2012/10/003074
• Lead Sponsor: InnoPharma Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1. Provision of signed and dated written informed consent prior to

any study specific procedures

2. Willing and able to comply with the study procedures, restrictions

and requirements

3. Adult males and females (of non-childbearing potential) aged 18 to 45 years (inclusive) at the time of signing informed consent

4. Body mass index (BMI) 19.0 to 25.0 kg/m2 (inclusive) and a body

weight of more

than 50 kg for males and 45 kg for females

5. Volunteer must be able to communicate effectively with the study

personnel.

6. Volunteer must be non-smoker and non consumer (user) of any

tobacco containing product (not consumed any form of tobacco in

the past 6 months)

7. In general good health as determined by an experienced physician

based on a comprehensive medical history and physical

examination. Minor abnormalities in laboratory testing are allowable

if not contraindicated by this protocol, and if in the estimation of the Investigator, pose no additional risk to participation nor interference

with study procedures

8. Adequate organ function as determined by laboratory

assessments within the institutional normal range including the

following parameters: hematology, serum chemistry and serology)

9. Subjects who are negative for hepatitis B surface antigen

(HBsAg), hepatitis C antibody and human immunodeficiency virus

(HIV) I and II tests at screening

10. Females must have a negative pregnancy test at screening and

on admission to the study centre, must be of non-childbearing

potential, confirmed at screening by fulfilling one of the following

criteria:

? Documentation of irreversible surgical sterilisation by

hysterectomy, bilateral oophorectomy or bilateral salpingectomy but

not tubal ligation

? Postmenopausal; Have attained menopause at least 1 year back

11. In case if childbearing, must be using a medically acceptable

form of birth control (such as foam, jellies, diaphragm, intra-uterine

device (IUD) or abstinence for the duration of the study as judged by

the Investigator

12. Male subjects should be willing to use a condom (with

spermicide) to prevent pregnancy and drug exposure of a female

partner and refrain from donating sperm or fathering a child from the

first administration of the investigational medicinal product until 3

months after administration of the investigational medicinal product

Exclusion Criteria

1. Participation in any investigational study or received an

investigational drug within a period of 3 months prior to admission in

period I.

2. History of drug abuse, or alcohol dependence or abuse.

3. History of any allergies (asthma, urticaria) including drug allergies

4. Known hypersensitivity or allergy to Nisoldipine or any of the

excipients or related

drugs

5. Presence of a clinically significant disorder involving the

cardiovascular, respiratory, renal, gastrointestinal, hepatic,

immunologic, haematological, endocrine, or nervous system (s) or

psychiatric disease or other condition that may interfere with the

absorption, distribution, metabolism or excretion of the

investigational medicinal product, or would place the subject at

increased risk, as determined by the investigator(s)

6. Volunteer whose:

? Systolic blood pressure less than 90 mmHg or more than 140

mmHg, diastolic blood pressure less than 60 mmHg or more than 90

mmHg after 5 minutes rest at screening or predose in Period I

? Sitting pulse rate below 55 beats per minute or above 100 beats

per minute after 5 minutes rest

? Respiratory rate below 10 or above 20 beats per minute

? Oral temperature less than 96.2°F or more than 99.8°F

7. Clinical laboratory test value outside the acceptable reference

range and when confirmed on re-examination and deemed to be

clinically significant

8. Subject who has donated blood in the 12 weeks prior to the

admission in Period I.

9. Clinically significant illness (any body system) during the 4 weeks

prior to admission in Period I (as determined by the investigators).

10. Subject who has consumed grapefruit, grapefruit juice or/and

grapefruit containing products, Seville oranges or quinine (tonic

water) within 96 hours prior to admission in Period I.

11. Use of any prescription drug(s) in the 14 days prior to admission in Period I or over-the-counter medication or herbal medications 14

days prior to admission in Period I.

12. Positive result in breath analysis test for alcohol.

13. Positive urine drug screening results for any of the following:

cocaine, tetrahydrocannabinol, barbiturates, amphetamines,

benzodiazepines, and opioids.

14. Positive results in cotinine test.

15. History of difficulty in swallowing tablets/ capsules.

16. Positive test for pregnancy for female subjects or lactating

females

17. Inability to be venipunctured and/or tolerate venous puncture

Study & Design

• Study Type: BA/BE
• Study Design: Not specified