Relative bioavailability study of Progesterone vaginal Suspension with applicator of with Crinone with applicator of Merck Specialities Pvt Ltd in healthy adult postmenopausal Female human subjects under fasting conditions

Not Applicable

Completed

• Registration Number: CTRI/2020/01/022885
• Lead Sponsor: incoln Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1 Healthy adult Post-menopausal female subjects aged up to 65 years.

2 BMI range from 18.5 to 30 kg/m2

3 Normal vital signs [blood pressure (Systolic 90-140 mmHg, Diastolic 60-90mmHg), pulse rate 60-100 beats/min), respiratory rate (15-20 breaths/min) and body temperature (96.0-99.8oF)]

4 Normal medical and surgical history as evaluated by the physician or principal investigator prior to start of the study.

5 Normal 12-lead electrocardiogram (ECG)&chest X-Ray (P/A)

6 Ability to communicate effectively.

7 Normal functioning cardiovascular, respiratory, gastrointestinal, nervous system, musculoskeletal, vascular, genitourinary, endocrine/metabolic systems.

8 No history of dehydration from diarrhoea, vomiting, excess sweating or any other reason within a period of 24.00 hours prior to study check-in.

9 Willing to provide written informed consent for participation in the study and adhere to the protocol requirements.

Exclusion Criteria

1.Contraindications or Hypersensitivity to progesterone or any other same class of steroids or to any of the components of the formulation or excipients.

2.History of peanut allergy.

3.Contraindications or Hypersensitivity to oral/some other contraceptive containing estrogen and progesterone or to any of the components of the formulation or excipients

4.History of DVT (Deep vein thrombosis) or pulmonary embolism.

5.History of jaundice.

6.History of breast and liver cancer.

7.History of vaginal bleeding.

8.History of Acute or chronic metabolic acidosis, Severe ketosis, diabetic coma or history of diabetic coma, type 1 diabetic patients(blood sugar control should preferably be done by insulin)

9.History of severe infection, surgery, severe trauma.

10.History of Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels >=1.5 mg/dL [males], >=1.4 mg/dL [females] or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia

11.History or presence of any disease (Gastric, renal, respiratory, cardiac, neurological etc.) according to the opinion of the physician.

12.History or presence of significant alcoholism or drug abuse in the past one year.

13.History or presence of significant smoking (more than 09 cigarettes or bidis/day) or consumption of tobacco products (pan, gutkha) and refusal to restrain from smoking for 48.00 hours before first period check-in until last sample collection.

14.History or presence of significant asthma, urticaria or other allergic reactions.

15.History of difficulty in donating blood or difficulty in accessibility of veins.

16.Use of any prescribed medication during last

14 days or OTC medicines or other medicinal products during the 7 day proceeding the first period check-in until completion of the study.

17.Major illness during 3 months before screening.

18.Participation in a drug research study within past 3 months.

19.Donation of blood in the past 3 months before screening.

20.Refusal to abstain from water for at least 1 hour prior to dosing and for at least 1 hour post dose.

21.Refusal to abstain from food for at least 10 hours before scheduled time for dosing and for at least 4 hours post dose.

22.Refusal to abstain from alcohol or methylxanthine-containing beverages or foods (coffee, tea, carbonated drinks, chocolate) from 48 hours prior to first period check-in until last sampling.

23.Presence of disease markers hepatitis B & C virus & VDRL.

24.HIV positive.

25.Found positive in the Alcohol breath test done at the time of check-in.

26.Found positive in the Urine drugs of abuse done at the time of check-in.

27.Anything where the subject is found unfit as per the physician opinion.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Cmax, AUC0-t and AUC0-â??Timepoint: Period I and period II

Secondary Outcome Measures

Name	Time	Method
Tmax, AUC_% Extrap_obs, λz and t1/2Timepoint: Period I and period II