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Pharmacokinetics of Mildronate Injection in Chinese Healthy Male Subjects: A Phase I, Open-Label, Crossover, Single- and Multiple-Dose Fasting Study

Pharmacokinetics of Mildronate Injection in Chinese Healthy Male Subjects: A Phase I, Open-Label, Crossover, Single- and Multiple-Dose Fasting Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TNC-10000939
Enrollment
Unknown
Registered
2010-07-02
Start date
2007-09-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Interventions

Group A:Each subject received in random order, single intravenous dose of 250, 500 or 1000 mg Mildronate in cycle. The interval for washout period of 3 times administration was 7 days.
Group B:Each subject was administered Mildronate 500 mg intravenously once daily for 14 days

Sponsors

Changchun Xiangtong Pharamceutical Co.
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 27 Years

Inclusion criteria

Inclusion criteria: 1. Body mass index(BMI) of 19 to 24 kg/m2; 2. No smoking, drinking or drug addiction before or during the study; 3. No history of cardiovascular, renal, gastrointestinal, hepatic, nervous, psychological disease or metabolic disorders.

Exclusion criteria

Exclusion criteria: 1. If they had been enrolled in another pharmacokinetic study, had donated blood or had been given other drugs for some therapeutic courses during the last 3 months; 2. Used caffeine-containing drink within 24 hours before the study

Design outcomes

Primary

MeasureTime frame
Concentration of Mildronate in human plasma and urine;

Countries

China

Contacts

Public ContactYongchuan Chen
zwmcyc@163.com+86 23 68765795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026